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N95 Respirator Manufacturers and Surgical Mask Suppliers

N95 Respirator Manufacturers

Since the coronavirus outbreak began in China and spread worldwide early this year, N95 mask manufacturers have witnessed a rapid soar in the sales of their respiratory protective products. The global fear of coronavirus pandemic has certainly become one of the top factors driving the exceptional growth of the global N95 respirator mask market in the first half of 2020. Under the current circumstance, many countries around the world have seen consumers stockpiling and panic-buying N95 masks and other respirator masks, which has caused a significant shortage of N95 masks in some of the markets. Despite some of the healthcare officials claim that healthy people don’t need to wear facial masks to prevent themselves from being infected by the coronavirus, the global demand of N95 masks continues to rise significantly, boosting the sales of some world’s largest N95 mask manufacturers in 2020.

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What is N95 Respirator Mask?

A respirator mask is a personal protective equipment that prevents the wearer from inhaling aerosols as well as vapors or gases that are health hazards. Unlike normal surgical mask that only protects against infectious droplets (e.g. droplets of saliva or other secretions), respirator mask can also protect the wearer from inhaling micro airborne infectious agents such as airborne virus (including coronavirus, SARS, H1N1, etc).

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Disposable Face Mask Supplier

Surgical Mask Manufacturer

N95 Respirator Manufacturer

FFP2 Respirator Suppliers 

In the US and many other countries, respirator mask must meet the industry standard, which has three grades of disposable respirator masks, known as N90, N95 and N99 (equivalent to FFP1, FFP2 and FFP3 masks in European standard)

  • N90 refers to an aerosol filtration of at least 80% and leakage to the inside of maximum 22%. This mask is mainly used as a dust mask (home renovations and various types of work).
  • N95 masks, also known as FFP2 masks in the European standard, have a minimum of 95% filtration percentage and maximum 8% leakage to the inside. They are mainly used in construction, agriculture, and by healthcare professionals against influenza viruses. As the most common and best-selling type of respirator mask, N95 masks have been proven effective for protection against the coronavirus.
  • N99 masks, also known as FFP3 masks in the European standard, are the most filtering masks in the market. With a minimum filtration percentage of 99% and maximum 2% leakage to the inside, they protect against very fine particles such as asbestos. It is the best mask to protect against coronavirus.

N95 Respirator Manufacturer Contact Us

Home Use Beauty Device Manufacturer China | Private Labeling and ODM

Reliance B&H offers high quality home use beauty devices with competitive price, effectiveness, cost-efficiency and safety. All RBH products are manufactured based on proven safety & efficacy, substantiated by rigorous use and scientific testing. Products include: Sonic Facial Cleansing Brush, Thermal Sonic Facial Brush, Blackhead Vacuum Remover, Ultrasonic Skin Scrubber, Microcurrent Face Lifting Massager, RF Skin Tightening, and LED Light Therapy devices. We have established OEM and ODM cooperation relationship with many international brands. Technical innovation, quality assurance and reasonable pricing are the business principles that all we pursue.Beauty device manufacturer.

 

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Air Purifier Manufacturer

Collagen  Mask Manufacturer

Beauty Device Manufacturer

 

*Design* — Good design speaks for product itself. Every of our skin care device is well designed to be unique to stand out in the market competition. Our creative designer team is always inspired by the market trends and customers’ ideas.

*Engineering* — Our Hardware and electric engineers work closely with our designers to balance the design and actual product structure. The coordination enables the fulfillment of an ideal design to be practical and cost effective.

*Tooling* — Our tooling, molding, and plastic injection center contribute to bring the design alive physically. There are usually several revisions to make sure the housing is perfect for mass production. It usually takes 45 days to finalize a new product mould.

*Assembly* — Skillful production staffs follow the SOP of each step to assemble the parts together into a workable device.

*Quality* — IQC for Materials. On site QC for whole assembly process. All is to make sure qualified products are shipped to customers.

 

Peal-off Mud Mask Supplier

Disposable Face Mask Supplier

Surgical Mask Manufacturer

N95 Respirator Manufacturer

FFP2 Respirator Suppliers 

 

Beauty Device Manufacturer

RBH aims to be a reliable partner offering quality beauty devices and adding value to our partners’ business. Welcome to send us a message if you like our beauty devices or just want to share ideas, WWW.RELIANCEBH.COM, Email: sales@reliancebh.com

Collagen Mask Supplier Full Turnkey Service & Innovative Result

Reliance B&H specializes in premium collagen Mask manufacturing & suppliers in China. we offer custom formulations and private label manufacturing services to build your brand.

Our concept is to provide clients with one-stop, no hassle service.

We take care of business from start to finish:  from concept to sampling to manufacturing and finally to a timely delivery. Our clients attain all the benefits of our costly investments in top-of-the-line equipment and facilities, product quality, storage, production arrangement and labor. RBH team allows you to accelerate your brand into the market and focus on building your business with greater flexibility.

Peal-off Mud Mask Supplier

Disposable Face Mask Supplier

Surgical Mask Manufacturer

N95 Respirator Manufacturer

FFP2 Respirator Suppliers 

GMP Certified production facilities with state of the art production equipment.

Our manufacturing plant are both GMP and ISO22716 certified, attesting to our advanced scientific know-how and thorough quality control validation steps, ensuring you only receive products of the highest caliber. Our QA department continually monitors processes according to the highest international requirements to guarantee optimal standards and product quality.

 

Good sense for new developments

RBH’s broad insight means we have a good sense for new developments. We seek out and identify trends. An idea can originate anywhere: from a raw material, smarter packaging, or equipment modification. We are passionate about sharing the most exciting ideas with our clients. To inspire them and to create new concepts together.

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Turns great ideas into great products.

We work collaboratively with clients on turning new concepts into products. What makes RBH unique is that we approach the whole process in partnership: from the marketing concept through development, and from production through sales.

VEDIO LINK :

https://www.youtube.com/watch?v=u7R5VHo6Sm0&t=20s

 

About Reliance B&H

Reliance B&H is your reliable partner in the development of beauty and health care products that ride the latest technology and feature innovative design. We have years of experience and strong ties with beauty & health manufacturers over China, ensuring that our customers always get what they want.  Our priority is to provide cutting-edge products, innovative marketing, impeccable customer service to all our professional clients. Our success is measured by the commitment to our customers and their long-term relationships with us.To view our products or to request a quote, please visit https://www.reliancebh.com/ or reach us through the following:

Email: sales@reliancebh.com

Peel-off Mud Mask Supplier Full Turnkey Service & Innovative Result

Masks of all types have recently become a trendy and practical addition to the product portfolios of many skincare, cosmetics, and spa companies. To provide new textures and comprehensive customized solutions to the overseas market, Reliance B&H’s Custom Manufacturing provides a full turn- key service, which enables RBH to service custom mask products from the very first step of R&D to the very end with filling & packaging. Explore new textures, formulations, and packaging options to add finished masks to your line of products.Peal-off mud mask supplier.

Hand Sanitizer Supplier

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Air Purifier Manufacturer

Collagen  Mask Manufacturer

Beauty Device Manufacturer

Mask Range (Peal-off mud mask supplier)

Reliance B&H is a leader of forward- thinking cosmetic concepts, formulations, and peel-off masks as well as unique collagen mask formulations. With two sites dedicated to cosmetic production, an expert team of R&D and Regulator Specialists, and extensive packaging & labeling equipment, Reliance B&H is able to personalize products to your needs and bring your specific concepts to life.

Peal-off Mud Mask Supplier

Disposable Face Mask Supplier

Surgical Mask Manufacturer

N95 Respirator Manufacturer

FFP2 Respirator Suppliers 

Peal-off mud mask supplier

Welcome to send us a message if you like our mask or just want to share ideas, WWW.RELIANCEBH.COM, Email: sales@reliancebh.com

How To Choose A COVID-19 related Supplier Under The New Policy of China Customs

In order to purchase medical supplies from China, you have to interpret the new Chinese Customs policy and understand how factories producing medical supplies are classified from Black List, White List, and Unconfirmed List.

As China passed Announcement No. 12 back on April 25 to implement stricter transportation regulations on medical supplies, the world watched on as Chinese Customs Officials ensured the orderly export of medical supplies in an attempt to achieve quality control. Although the overall goal of Announcement 12 further helped Chinese customs officials remove invalid and fraudulent PPE from the export market, it also caused a large backlog of challenges in products and transportation.

However, according to informed sources in China, the current situation has been greatly alleviated as the supply chain moves steadily forward.

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In order to purchase medical supplies from China, you have to interpret the new Chinese Customs policy. Announcement 12 classifies the factories that produce all medical supplies in China into the following categories:

  1. Black List: This part of the factory has a history of exporting undesirable medical supplies. China Customs permanently prohibits this part of the factory from exporting medical supplies. Pay attention to whether the factory is on the Chinese blacklist when purchasing.
  2. White List: This part of the factory has obtained corresponding certifications from other countries, such as NIOSH in the United States, CE certification in the EU, TGA certification in Australia, etc. This part of the factory is counted by the Ministry of Commerce of China and verifies the authenticity of the certificate. It can take priority in export declaration to avoid risks such as flight delays caused by inspections.
  3. Unconfirmed List: This part of the factory is neither on the Black List nor on the White List. We call it the Unconfirmed List, as it will be subject to the most stringent inspection by the Chinese Customs Officials when exporting customs. The Chinese Customs will even conduct commodity inspections on the products. It will take a few days, resulting in delays and may incur huge costs (such as inspection fees, warehouse rental fees, dead freight). If the final commodity inspection results indicate that it is a bad product, the customs may confiscate the goods. The factory moved to the Blacklist and will be imposed the strictest punishment.

In addition, Chinese Customs requires the factory to provide a document with a common declaration when exporting customs, which means that when exporting non-medical masks, companies can export only according to Chinese standards or destination country standards. As for which standard is selected for export, this is negotiated by the buyer and the seller. It is worth a reminder that only when the factory is on the White List, the destination national standard can be selected for export during export declaration, otherwise the Chinese standard can only be selected for export declaration.

Peal-off Mud Mask Supplier

Disposable Face Mask Supplier

Surgical Mask Manufacturer

N95 Respirator Manufacturer

FFP2 Respirator Suppliers 

It raises a question, how do companies, hospitals, and healthcare professionals choose suppliers under the new policy of China Customs?

It’s not only about purchasing medical supplies, but also about ensuring that the goods meet procurement needs and meet the export requirements of the Chinese customs. Following a few simple steps has proven to be effective:

  1. Check whether the factory belongs to the Blacklist, and refuse to cooperate with the Blacklisted factory to avoid the quality problems of the purchased goods and the export of customs declaration.
  2. If you need to purchase non-medical masks that meet the national certification of the destination, please select the factory on the Chinese White List. This part of the factory has obtained the relevant certification of the destination country and is counted by the Chinese Ministry of Commerce to avoid the false certification documents and risk.
  3. If you only need to purchase non-medical masks that meet Chinese standards, this does not require the factory to be on the White List, but requires that the test report must be valid (must be a testing agency above the provincial level and approved by MA, CNAS and other organizations Issued), all the information in the certificate documents must be consistent to deal with the strict inspection of the Chinese customs, in order to successfully be exported.
  4. If you are purchasing medical supplies(new Coronavirus detection reagent, medical mask, medical protective clothing, ventilator, infrared thermometer), be sure to select the factory on the White List to ensure that the goods can be exported normally.
  5. Choose professional third-party inspectors, such as a professional forwarder. Keep in touch throughout the process, as they can keep you abreast of China Customs’ export requirements for medical supplies. They can also provide professional advice on some details to declare customs in China will not run into trouble.

The above precautions can make it simple for you to purchase medical supplies in China, and helps avoid many risks and losses along the way during the supply chain process.

 

Planning on importing medical products, but unsure about it, or need help?

We’re helping clients globally undertake due diligence on medical suppliers, inspecting products before shipping, and much more. If you’re stuck, perhaps we can help!

Get help from RELIANCE B&H

oem&odm

oem&odm

 

Automatic Touchless Hand Sanitizer Dispenser

Reliance B&H offers a variety of commercial hand sanitizer for healthcare facilities, retail stores, restaurants, offices, grocery stores, and convenience stores. Providing a means for people to keep their hands clean hands is a priority since Covid-19. Hands-Free anti-bacterial stations are considered personal protective equipment (PPE). Our touchless hand sanitizer dispensers are a convenient way to promote the health and safety of others while helping to protect your staff and customers from the spread of bacteria and viruses.

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Automatic hand sanitizer dispenser supplier

Commercial Hand Sanitizer Dispenser

dispancer

hand dispencer

Increase the health and safety of your employees and customers with an automatic hand sanitizer dispenser. Reliance B&H creates custom hand sanitizer units with your company logo and graphics.

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Reliance B&H has a Variety of Sanitation Products Available:

  • Automatic Hand Sanitizer Dispenser
  • Automatic Hand Sanitizing Station
  • Bulk Hand Sanitizer
  • Business Hand Sanitizer Dispenser
  • Commercial Hand Sanitizer Station
  • Hand Sanitizer Dispenser Stand
  • Hand Sanitizer Dispenser Station
  • Hand Sanitizer Dispensers
  • Hand Sanitizer Floor Stand Station
  • Hand Sanitizer Stations For Businesses
  • Hand Sanitizer Stations For Stores
  • Hand Sanitizer Wall Stand
  • Hand Sanitizer Station Stand
  • Hand Wash Station Portable
  • Office Hand Sanitizer Dispenser
  • Office Hand Sanitizer Station
  • Outdoor Hand Sanitizer Station
  • Portable Hand Sanitizer Basin
  • Portable Hand Sanitizer Dispensers
  • Portable Hand Sanitizer Floor Unit
  • Portable Hand Sanitizer Station
  • Portable Hand Sanitizer Unit
  • Touchless Hand Sanitizer Dispenser
  • Touchless Hand Sanitizer Station
  • Touchless Hand Sanitizing Station
  • Automatic hand sanitizer dispenser supplier

Automatic Touchless Hand Sanitizer Dispenser

Reliance B&H understands the importance of demonstrating sanitation and safety measures. We provide automatic touchless hand sanitizer dispensers designed for the convenience and protection of your staff and customers. Our automatic touchless hand sanitizer dispenser look professional, are convenient, and can be customized to suit your needs.

Custom Private Label Hand Sanitizer Dispenser –Reliance B&H offers fast delivery of automatic hand sanitizer dispenser supplier for public health and safety.

handsan

 

Hand Sanitizer Liquid in Bulk

Contact us about your Covid-19 supply needs and check out our

 BEAT COVID-19 Products
www.reliancebh.com

 

Reliance B&H Offer Hand Sanitizer Custom Private Label Service For Overseas Buyers

As the world faces the health crisis of COVID-19, many hand sanitizer suppliers commit their production resources to make custom hand sanitizers for private labels. This is a response to the shortage of hand sanitizers affecting not just health services but the entire community of many countries. Among these suppliers is Reliance B&H, which has increased their production capacities to meet the rapid increase in demand for hand sanitizers.

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Bealthy Hand Sanitizers

Hand sanitizers supplied by Reliance B&H contain 75% alcohol content, which is recommended during this health crisis. These sanitizers also contain moisturizing ingredients to protect the skin.

“As we battle this COVID-19 crisis, the company commits to providing hand sanitizers effective in proper hand hygiene. There is a severe shortage of alcohol in many countries today, and our way of helping is to supply hand sanitizers that contain enough alcohol content to make them a great alternative when washing hands is not convenient,” a Reliance B&H representative shares.

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hand sanitizer

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Bealthy Hand Sanitizer Gel

Sanitizer gels can be customized according to brand requirements, such as the container and printing logo. Clients can also choose the content, such as waterless, alcohol content, and alcohol-free.

About Reliance B&H

Reliance B&H is a hand sanitizer supplier from China that has been in operations for more than 10 years. The company has earned complete export qualifications, including Dangerous Goods Transport Packaging Report, FDA, MSDS, and CE. Reliance B&H offers hand sanitizer gels and also welcomes private label services or OEM. To view its products or to request a quote, please visit https://www.reliancebh.com/ or reach them through the following:

Email: sales@reliancebh.com

Suspicious certificates for PPE

remark : this article is valid for Personal Protective Equipment (PPE), such as protective masks (type FFP2 or FFP3), protective glasses and face shields, protective gloves and garments, etc. The conformity assessment procedures for medical devices (e.g. medical or surgical masks) are different and for those you should seek information from the relevant trade associations or authorities. The manufacturer must also check of other legislation is simultaneously applicable to the product (e.g. REACH is always applicable).

 

 

Everybody is working very hard and with the best intentions to make the necessary PPE available to the healthcare workers and other people involved in the fight against the COVID-19 crisis.

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Disposable Face Mask Supplier

Surgical Mask Manufacturer

N95 Respirator Manufacturer

FFP2 Respirator Suppliers 

In first instance the Declaration of Conformity (DoC) has to be provided and checked. For products imported from outside the EU (including EFTA and other participants to the single market), the importer has to make sure that the manufacturer has done the conformity assessment as foreseen in the PPE Regulation (EU)2016/425. In case where their is doubt about the DoC or there is no DoC available or there is import from outside the EU, it makes sense or is even necessary to check the certification. See the articles “what to do when importing PPE (e.g. FFP2 masks) to the EU ?” and “conformity assessment procedure for PPE

Unfortunately, we (the European Safety Federation (ESF) = trade association of suppliers of PPE, a not for profit organisation funded by the members) are informed by different sources about ‘certificates’ or other documents used as basis for CE marking of PPE (including FFP2/FFP3 masks and eye protection), while these ‘certificates’ have no legal value and can not be used as conclusion of conformity assessment. It is not clear if these documents have actually been issued by the organisations mentioned themselves or if they are fake (we have the impression that a lot of fake documents are being presented as proof of compliance). ESF is not accusing them of doing so, we only want to inform and warn about these documents.

Several of the mentioned institutes offer the possibility to check the validity of the ‘certificate’ on their website. In those cases, a ‘valid’ response does not make the document a legally valid type examination certificate. It only means that the institute recognises that they have issued the ‘certificate’ to this producer for the mentioned product.

So far we have seen ‘certificates’ on letterhead (or using their logo and/or name) of the following institutes based in Europe (examples at the bottom of this page) – the institutes are not a notified body competent for PPE mentioned in the document or the documents are fake :

  • ICR Polska – see update 31/03/2020, 06/04/2020 and 14/04/2020 below – ICR is not a notified body for PPE (they are for other products)
  • CELAB – see statement on their webpage https://celab.com/en/coronavirus/ – CELAB is not a notified body for PPE (they are for other products)
  • ECM (Ente Certificazione Macchine) – also a picture of a mask with identification number of the notified body ECM 1282 next to CE – ECM is not a notified body for PPE (they are for other products), so this marking is certainly not valid) – see update 03/04/2020 below
  • ISET (Instituto Servizi Europei Technologici) – on their website they have a page with false certificates – see http://www.iset-italia.eu/index/service/fal.html – ISET is Notified Body for some types of PPE, but not for respiratory protection (masks)
  • NPS
  • Amtre Veritas
  • STS Inspection and Certification
  • VIC Testing and Certification
  • BSI Test Limited : we have also added an example of a ‘certificate of compliance’ issued by ‘BSI Test Limited, London’ which is clearly not issued by the Notified Body for PPE BSI and this is confirmed by the Notified Body BSI – so this one is not a valid EU Type Examination certificate.
  • ISP (UK Inspec International) : the document as example is titled ‘declaration of conformity’ but the text refers to ‘certificate’
  • NTC (Nationaux de Certification Technique – CHCS)
  • Ecole Supérieure du Bois : This institute provided us the example. The name and address of the Ecole Supérieur du Bois in France is used together with the name Euroscene Business Solutions Limited. The Ecole Supérieure du Bois is active in construction products and confirms that they do not issue certificates for PPE. They have no relationship with Euroscene Business Solutions Limited. This is clearly a fake document abusing their name.
  • Sapo (Sapo Certification & Testing Laboratory Limited)

We have seen falsified (type examination) certificates using the name, logo and/or layout of the following Notified Bodies for PPE (examples at the bottom of this page). These are not issued by themselves, so they are a victim of fraude and can not be blamed for this abuse :

  • BSI : we have an example of a BSI EU Type Examination Certificate that has clearly been changed and is thus a fake document – this is confirmed by the Notified Body for PPE BSI. Certificates of BSI can be verified on https://verifeyedirectory.bsigroup.com/
  • VUBP (Vyzkumny ustav bezpecnosti prace) : we received an example of a ‘certificate of conformity’ using the name and logo of VUBP. This example has been confirmed by the Notified Body VUBP to be fake
  • CSI : CSI sent us an example of a fake certificate for masks using their name and NB number. CSI is a notified body for different types of PPE, but not for respiratory protection. There is no doubt that the example is a fake document
  • Apave Sudeurope : we received an example of an Apave EU Type Examination certificate – this document is not issued by the Notified Body Apave and is confirmed by them to be a fake document.
  • Centexbel : we received examples from Centexbel of type examination certificates that have been falsified – so confirmed by them to be fake documents.

So far we have seen ‘certificates’ on letterhead (or using their logo and/or name) of the following institutes based in India (examples at the bottom of this page). In any case, a certificate issued by an institute in India is not a legally valid type examination certificate as these can only be issued by a Notified Body with the type of PPE concerned in their scope. So the ‘certificates’ by such organisations are no legal basis for CE marking nor for placing the PPE on the EU market.

  • TQV Certification Services

So far we have seen ‘certificates’ on letterhead (or using their logo and/or name) of the following institutes based in China (examples at the bottom of this page). Be aware that some of the documents we have seen from Chinese institutes claim FFP2 masks to be PPE category I – this is clearly not correct, protective masks are always PPE category III. Some of the documents are also fake and not issued by the mentioned institute. In any case, a certificate issued by a Chinese institute is not a legally valid type examination certificate as these can only be issued by a Notified Body with the type of PPE concerned in their scope. So the ‘certificates’ by such organisations are no legal basis for CE marking nor for placing the PPE on the EU market.

  • ENC (East Notice Certification Service)
  • HTT (Shenzhen HTT Technology)
  • BTK (Guangzhou Bestek Testing Services)
  • Huawin (Shenzhen Huawin Testing Certification)
  • LTT (Shengzhen LTT Testing Technology)
  • JZ-CERT (Shanghai Jian Zheng Network Technology)
  • OCT Technology Testing
  • ACT Testing Technology
  • XW-CERT (Shenzhen XinWei Certification Service)
  • YouBest Testing Technology
  • Shenzhen Tian Hai Test Technology
  • BST (BST Testing Service International, Hong Kong)
  • CTE (Coffee-T Electronics Technology)
  • CTO (Shenzhen CTO Technology Service)
  • Huacetong (Shenzhen Huacetong Testing and Certification)
  • STA (Shenzhen STA Testing)
  • STE (STE Testing Laboratory)
  • Bory (Shenzhen Bory Technology Service Co., Ltd,)
  • Zuoce (Zuoce Certification and Testing Center)
  • HCS (Hwatest Compliance Services Co., Ltd.)
  • BEL (Shenzhen BEL Technology Co., Ltd.)
  • EUKey (EUKey Testing and Technology Co., Ltd.)

Also ‘declaration of conformity’ on letterhead of institutes (or using their logo and/or name) that are confirmed by the concerned organisations to be false (not issued by themselves, so they are a victim of fraude and can not be blamed for this abuse) :

  • Nova Certification (based in Greece) – the Notified Body Nova (not notified for PPE assessment but for other types of products) confirmed that the example of the ‘declaration of conformity’ is a fake document
  • GTS (Global Testing Services, based in China) – this organisation confirmed that the example shown is not issued by themselves and is thus a false document (the reference on the document is an existing reference for a document related to a Forehead thermometer and RoHS legislation). On their website http://en.gts-lab.com/ser.htm you can check the reference of the document.

Organisations based in China from which we received information that the example given is not issued by themselves and thus false. This means that their name is abused and that they can not be blaimed for this abuse.

  • Micez (Shanghai MICEZ Testing & Technical) – 14/04/2020 : Micez informed that the example on this page is not issued by Micez and thus fake !
  • ITC (Shenzhen ITC Product Testing) – 18/04/2020 : ITC informed that the example on this page is not issued by ITC and thus fake !
  • Huaxun (Shenzhen HX Detect Certification) – 21/04/2020 : Shenzhen HX Detect Certification informed that the example on this page is not issued by Shenzhen HX Detect Certification and thus fake !
  • ATL (Shenzhen ATL Testing Technology) – 21/04/2020 : ATL informed that the example on this page is not issued by ATL and thus fake !
  • Beidor (Shenzhen Beidor Testing Technology) – 26/04/2020 : Beidor informed that the example on this page is not issued by Beiror and thus fake !
  • TMC (TMC Testing Services (Shenzhen)) – 26/04/2020 : TMC informed that the examples on this page are not issued by Beiror and thus fake !
  • CCT (Shenzhen CCT Testing Technology) – 27/04/2020 : CCT informed that the example on this page is not issued by CCT and thus fake !
  • CIC (Shenzhen CIC Testing Technology) – 27/04/2020 : CIC informed us about a statement on their website clarifying that all certificates issued by CIC for PPE are certainy withdrawn – see http://www.soncap-saso.com/en/article/20200404/503.html
  • TXB (TXB Rheinland Testing Services) – 28/04/2020 : TXB informed that they never issued CE certificates for PPE and thus that any certificate for PPE with their name on it is fake !
  • FFP2 respirator suppliers

We have the impression that manufacturers outside the EU (and probably even ‘newcomers’ and importers in the EU) are not entirely familiar with the EU Legislation on PPE and thus believe that by paying the ‘certificate’ from such an organisation,  they are fully in compliance with the EU legislation. And most likely, also on the side of the customers (including health authorities), the knowledge about the exact requirements of the EU legislation is lacking and thus they judge those documents as accurate.

It has to be remarked that it is possible that the PPE are safe and offer the claimed protection, even if the documents are not correct and thus offer no solid proof of that. In those cases, testing of the PPE and following the correct procedures can be considered.

At this moment, it is clear that the priority is to get as much as possible masks (and other relevant PPE) into the EU so that the healthcare workers can be protected. On the other hand, it cannot be accepted that sub-standard masks which offer not the claimed protection are made available to healthcare workers that are now at high risk and thus deserve correct protection.

Protective masks (like FFP2/FFP3) are PPE of category III according to the Regulation (EU)2016/425. This means that the conformity assessment includes a type examination by a notified body, resulting in a ‘EU type examination certificate’ as well as production follow-up by a notified body (random checks or system audit). This results in CE marking with the number of the notified body responsible for the production follow-up next to the CE marking. The manufacturer is obliged to issue the EU Declaration of Conformity, which must accompany (at list via a weblink) the PPE, together with the instructions for use.

Given the current health crisis, the EU Commission published Recommendation (EU) 2020/403 on conformity assessment and market surveillance. This allows for member states to be flexible only for products relevant to the crisis and bought for the duration of the crisis (by authorities) for the healthcare sector. But this does not mean that the products do not have to be in compliance with the applicable essential health and safety requirements defined in the PPE Regulation, and certainly not that they do not need to offer the claimed protection. See for more information on this the article “exceptions to the conformity assessment rules for PPE

PPE entering the normal distribution chain however, still have to be fully compliant with the Regulation.

For everyone involved : check that ‘certificates’ you receive for the PPE are correctly titled ‘EU type examination certificate’ and that they are issued by a competent Notified Body (meaning certainly based in the EU, including EFTA and Turkey). The identification number of the Notified Body has to be included in the EU type examination certificate.

If you have doubts about the Notified Body, you can check the NANDO database (https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=155501) where you will find also the competences of the notified bodies (not all PPE notified bodies are competent for all types of PPE).

If you have doubts about the EU type examination certificate, do not hesitate to contact the notified body concerned with the question if the certificate is genuine and valid to prove compliance to the EU PPE legislation (some of the notified bodies have a tool on their website to check certificates).

In case of doubt or in case of a non legally valid document, you can contact the national market surveillance authorities in the Member State where you are based or where the PPE are destined for.

You can also contact the national organisation of PPE suppliers in your country (see the effective members of ESF for contact information).

For some more information on how to recognise ‘misleading’ or ‘fake’ certificates, see also the ESF Q&A 87 and Q&A 88

The China National Accreditation Service (CNAS) has published a list of laboratories accredited for testing of masks (protective and medical) on their website. Remark : Chinese accredited laboratories are certainly not Notified Body for respiratory protection and thus cannot issue EU Type Examination Certificates, they can perform the testing according to the tests for which they are accredited (in the majority of cases this is only to the Chinese standards, not to the EN standards). click here for the list of CNAS

update 31/03/2020 (see also update 06/04/2020 and 14/04/2020) : ICR Polska placed a message on their homepage concerning their voluntary certificates (see https://icrpolska.com/) :

Due to the increased interest in obtaining a certificate of compliance with the standards harmonized with the European Commission Regulation on personal protective equipment No. 2016/425, we would like to inform that ICR Polska Co, Ltd. no longer accepts applications for certification on this scope.

At the same time, we explain that, in accordance with the content of issued certificates, the assessments carried out so far are of a voluntary nature and are not equivalent to the mandatory conformity assessment procedures carried out by Notified Bodies authorized to the aforementioned Regulation. These certificates do not confirm conformity with all essential requirements of Regulation No. 2016/425 relating to the product.

update 03/04/2020 : ECM sent us the following information concerning the abuse of their notified body number, fake certificates and voluntary certificates :

We would like to state that we are not a Notified Body for PPE and therefore cannot and are not releasing any CE certification for this directive. We are aware of the blatant misuse and forgery of certificates reporting our NB number 1282, like the one you have correctly reported in your article. The use of our name and number on PPE masks is a fraud and an abuse, and we are taking steps to trace and report all fake certificates circulating.

We update our database of fake certificates and the news section of our website almost daily, with any new fakes we discover, but unfortunately it is difficult to trace them all. We also immediately proceed with the required reporting as soon as we get news of a new fake.

To this regard, we would greatly appreciate if you could please let us know the name of the company who is importing PPE masks with our CE number so we can report it immediately. We do not want fake CE certificates with our NB number to circulate, as they risk endangering the users and are a serious issue for our company.

We would also like to underline that any activity performed in regards to the PPE directive has been a voluntary review of technical documentation, and cannot substitute a CE certification in any way. Manufacturers and consultants who have requested this service are aware of the voluntary nature of this type of verification and have agreed on the terms and conditions of the service, conducted according to our voluntary mark regulation, published on our website.

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To this regards, we kindly ask you let us know if you encounter any certificates or improper use of our NB number and logo, so that we can proceed reporting it to the authorities.

To this regard, I would like to direct you to our website, where we have addressed (and are continuing to address) the matter in more detail, through the following link : http://entecerma.it/news

update 06/04/2020 : ICR Polska changed the text that was placed on their website on 31/03/2020 – see new update on 14/04/2020.

Dear Sir or Madam,
– you can check the status of the certificate yourself: https://cert.icrpolska.com

– in case of problems with finding the certificate, please attach its scan and send an email to icrpolska@icrqa.com

– at the same time, we would like to inform you, that import of products onto the EU market depends on meeting legal requirements applicable to the product e.g.:

– Regulation 2016/425
– Directive 94/42/EEC

– we encourage you to read: https://op.europa.eu/en/publication-detail/-/publication/a247dab0-6794-11ea-b735-01aa75ed71a1/language-en

update 14/04/2020 : ICR Polska changed again the text on their website – see https://cert.icrpolska.com/

annexes to the article (examples of suspicious certificates) can be seen here (click on ‘example …’ to open the file) – some of the documents are fake. In any case none of the shown examples are legally valid type examination certificates :

Planning on importing face masks to the USA, but unsure about it, or need help?

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USA Disposable Face Mask & Respirator Importing FAQs

  1. How does a respirator factory become officially certified to export to the USA?

The supplier will have to undergo NIOSH certification which costs about $8,000 per year and includes annual factory assessments by NIOSH inspectors. The certification process is very strict, which is why NIOSH-certified products are usually only acceptable for healthcare usage, as they are proven to provide a high and trusted standard.

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Here are some quick NIOSH certification knowledge points:

  • Each mask production facility must hold its own certification.
  • Each model of mask requires a separate certification (as some factories may make more than one type).
  • Typical lead time from when a mask certification application is submitted to when it is approved is 6 months (any changes to any aspect of the product will require another 6 month lead time for re-certification).
  • An on-site testing lab will need to be put in place.
  • FFP2 respirator suppliers

In the long-term a NIOSH-certified factory also needs to become FDA-certified, too, in order to export to the USA. They will notify the FDA of their intent to market medical devices by submitting a 510 (k) clearance.

 

  1. Have the usual policies for importing foreign PPE into the USA been relaxed due to the coronavirus pandemic?

Surgical masks

Yes, the FDA will not object to surgical masks may be imported, distributed, and used during the coronavirus pandemic without compliance with the following regulatory requirements where the surgical mask does not create an undue risk in light of the public health emergency:

  • Prior submission of a premarket notification under section 510(k) of the FD&C Act and
    21 CFR 807.81,
  • Registration and Listing requirements in 21 CFR 807,
  • Quality System Regulation requirements in 21 CFR 820,
  • reports or corrections and removals in 21 CFR Part 806,
  • Unique Device Identification requirements in 21 CFR Part 830 and 21 CFR 801.20.

Respirators

Yes, the insistence on adherence to the NIOSH performance standard has been temporarily relaxed during the coronavirus pandemic, and importers are able to bring in correctly-certified Chinese ‘KN95’ standard FFR respirators (and those from other countries) during this time.

FFP2 respirator suppliers

The CDC has released a list of Authorized Imported, Non-NIOSH Approved Respirators Manufactured in China.

The FDA states:

“As part of a set of crisis management recommendations,
the FDA identifies alternatives to FDA-cleared or NIOSH-approved N95 respirators approved under standards used in other countries, some of which were evaluated under methods that are similar to NIOSH-approved N95 respirators. For the duration of the public health emergency, when FDA cleared or NIOSH-approved N95 respirators are not available, FDA does not intend to object to the distribution (including importation) and use of respirators identified in the CDC recommendations without compliance with the following regulatory requirements:

  • Prior submission of a premarket notification under section 510(k) of the FD&C Act and 21 CFR 807.81,
  • Registration and Listing requirements in 21 CFR 807,
  • Quality System Regulation requirements in 21 CFR 820,
  • Reports of corrections and removals in 21 CFR Part 806, and
  • Unique Device Identification requirements in 21CFR Part 830 and 21 CFR 801.20.

Because FDA cannot confirm the authenticity of the respirators described above, FDA recommends that importers take appropriate steps to verify the authenticity of the products they import.”

Despite the FDA’s EUA (Emergency Use Authorization) allowing the importation of non-NIOSH approved respirators, there are still certain requirements in place:

  • The KN95 FFR must either:
  1. Be manufactured by an entity which holds a NIOSH certification for other model/s.
  2. Have regulatory approval from a non-Chinese entity which is FDA-verified.
  3. Or have documented testing reports that the FDA can peruse and verify.
  • The FDA must be supplied with a review of the product by the manufacturer which they then approve.
  • Manufacturers are expected to publish intended use information, notify users and importers about any changes, and provide the FDA with reports.
  • Importers must ensure that the KN95 FFRs meet CDC/FDA requirements and must clearly state that they do notsuggest that the product is ‘safe or effective’ at stopping covid19.

This summary comes from an FDA letter regarding importation of KN95 FFRs to the USA dated 4/3/20- read it in full here.

 

  1. Has China increased restrictions on PPE products which can be exported?

Yes, they have, and this will affect importing face masks from China to the USA.

In response to a market which was getting out of control, on 4/1/20 China increased restrictions on who is allowed to export PPE (free registration to read articles) and has created an official list of authorized medical goods exporters. This may restrict availability, but will help to ensure better-quality products are exported following various high-profile cases of defective PPE being shipped overseas from China.

Here is a summary of the government’s order (courtesy of China Law Blog and you may read the full official Chinese government page here):

The title is Order Concerning the Orderly Export of Medical Supplies 关于有序开展医疗物资出口的公告.

The Order was issued effective April 1, 2020 jointly by the Ministry of Commerce, the Customs Bureau and the National Medical Products Administration. The Order is temporary and can be expanded or revoked at any time. The text of the Order and its supplementary exhibits can be found here (in Chinese only).

The Order applies to the export of the following medical supplies:

  1. Novel Coronavirus Test Kits 新型冠状病毒检测试剂.
  2. Medical Use Face Masks 医用口罩.
  3. Medical Use Protective Clothing 医用防护服.
  4. Ventilators 呼吸机.
  5. Infrared External Thermometers 红外体温计.

For the listed products, the exporter must meet two requirements. First, the product or device must be registered in China having obtained a PRC Medical Device Product Registration Certificate. The exporter must provide the registration number for the product/device as a requirement for export. As an exhibit to the Order, a spreadsheet is provided that lists all entities that have obtained this required certification. For many products, the number of certified companies is very small. Second, the product or device must comply with the quality standards of the importing country. How this proof is to be provided is not stated.

FFP2 respirator suppliers

The Chinese exporter is required to submit a signed form to China customs stating the required information and affirming its accuracy. A copy of this form is included as an exhibit to the Order. Exporting under an inaccurate or falsified statement subjects the exporter to liability under Chinese law.

If you’re buying from a Chinese supplier, they are responsible for fulfilling the government’s requirements, but you as the buyer also need to take responsibility for checking that they do because these days we’ve seen that most suppliers are requesting payment up front for the goods.

Imagine the scenario where you have paid in full for an order of PPE, only then to find out that the supplier is prohibited from exporting the goods to your country? It is not guaranteed that you would be given a refund!

 

  1. What is the lead time on performing the lab tests required for mask certification?

We have recently checked with local testing labs in China (as of 4/7/20) and they are quoting up to 10 months lead time to perform tests. Even for a single test, for example a BEF test for surgical masks, the lead time is one month. This should be borne in mind by importers seeking to check their products.

 

  1. Can I check if a potential face mask supplier is already FDA-certified?

Yes, you can use the FDA’s website here. Just input as much of the supplier’s company information that you know as possible.

Also, remember to check the scope of the supplier, as this will show you whether they actually provide the types of masks that you are trying to import.

 

  1. Where can I see the complete list of NIOSH-approved N95 respirator suppliers?

You can check an alphabetical list of NIOSH-approved respirator manufacturers on the CDC’s website here.

  1. Which Chinese laboratories are authorized to lab test surgical masks & PPE?

The laboratory tests for Chinese standards should be performed by a lab that is listed in this directory and is authorized for this kind of product.

 

  1. The face masks or respirators I am trying to buy from China do not mention ‘medical’ or ‘surgical’ in the product description. Are they safe?

As shown on this page, the FDA has many regulations for surgical masks and respirators that are meant to be used for medical purposes.

To circumvent the time it takes to become properly certified for export to the USA or EU, many Chinese companies are exploiting a loophole where FDA regulations are fewer for non-surgical PPE. (Source: FT – paywall) These masks often look the same as their ‘for medical use’ cousins, which is part of the problem.

While these items may provide some kind of protection, they likely do not meet the strict pharmaceutical testing criteria which provide the best protection against infection applied to items for medical use. Therefore it is prudent to check the item’s product code to confirm the mask type via the FDA product classification online database.

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FFP2 Respirator Suppliers 

 

  1. What can I do to reduce my risks when purchasing face masks or other medical supplies from China?

Even if you can’t run new lab tests, you can focus on paperwork, auditing, and inspections to reduce risks:

  • Due diligence on suppliersbefore placing orders – are they legitimate manufacturers, are they legal?
  • Certificate verification– is their CE certificate real? Are the documents they provide for the correct products?
  • Factory audits– this may be more effective if you are placing very large orders (millions of pieces), but they will allow you to know that the factory is capable of producing the products you need at the right standards.
  • Product inspections– gives you the security that your products are good quality before they are shipped.
  • FFP2 respirator suppliers

 

  1. I’m importing face masks into the USA. Do I need to be FDA-registered?

Yes, you do. You can register here.

 

Planning on importing face masks to the USA, but unsure about it, or need help?

We’re helping clients globally undertake due diligence on PPE suppliers, inspecting products before shipping, and much more. If you’re stuck, perhaps we can help!

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Regulations Common To Both Face Mask & Respirator

Face masks used for protection during the Coronavirus pandemic, and in any healthcare setting, belong to the product category of ‘disposable medical PPE. We can generally categorize PPE face masks 3 ways:

1.Surgical face mask (medical face mask) – vary from 3 to 5 ply thickness

2.N95 Respirators – vary based on oil-resistance and filtration percentage

3.Regulations common to both Medical Face Masks and Respirators

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FFP2 Respirator Suppliers 

You may find the FDA’s Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency useful.

This outlines some of the policy changes they have implemented during the crisis, including the relaxation of some regulations you will see in this section.

These regulations will usually be in place for importers who are importing face masks from China to the USA, or those sourced from other foreign countries, too.

 

FDA 21 CFR regulation for surgical masks & respirators

Surgical masks and respirators are FDA classified under 21 CFR 878.4040 which lays out requirements for importers including:

  • Prior submission of a premarket notification under section 510(k) of the FD&C Act and 21 CFR 807.81,
  • Registration and Listing requirements in 21 CFR 807,
  • Quality System Regulation requirements in 21 CFR 820,
  • reports or corrections and removals in 21 CFR Part 806,
  • Unique Device Identification requirements in 21 CFR Part 830 and 21 CFR 801.20.

The following will be made clear in order to import, distribute, and use surgical masks and respirators

  • Identification
  • Classification
  • Analysis and Non-clinical testing
  • Usability performance
  • Labeling requirements
  • Warning and precautions

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510(k) premarket FDA clearance

Surgical mask manufacturers or importers are required to submit a 510(k) premarket notification to gain the FDA’s clearance to import and sell the products in the USA.

There is a 90 lead time between submitting the 510(k) and being able to place the products on the market.

A 510(k) will include the following (read the format from the FDA here):

  • (1) Medical Device User Fee Cover Sheet (Form FDA 3601)
  • (2) Center for Devices and Radiological Health (CDRH) Premarket Review Submission Cover Sheet (Form FDA 3514)
  • (3) 510(k) Cover Letter
  • (4) Indications for Use Statement (Form FDA 3881)
  • (5) 510(k) Summary or 510(k) Statement
  • (6) Truthful and Accuracy Statement
  • (7) Class III Summary and Certification
  • (8) Financial Certification or Disclosure Statement
  • (9) Declarations of Conformity and Summary Reports
  • (10) Device Description
  • (11) Executive Summary/Predicate Comparison
  • (12) Substantial Equivalence Discussion
  • (13) Proposed Labeling
  • (14) Sterilization and Shelf Life
  • (15) Biocompatibility
  • (16) Software
  • (17) Electromagnetic Compatibility and Electrical Safety
  • (18) Performance Testing – Bench
  • (19) Performance Testing – Animal
  • (20) Performance Testing – Clinical

If any sections are not applicable, they will be included in the document, but can be denoted as ‘N/A.’

In order to make the submission, the mask manufacturer or importer will also need to create an online account with the FDA in order to do so.

 

Planning on importing face masks to the USA, but unsure about it, or need help?

We’re helping clients globally undertake due diligence on PPE suppliers, inspecting products before shipping, and much more. If you’re stuck, perhaps we can help!

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