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.

Hand Sanitizer Supplier

Automatic Hand Sanitizer Dispenser Supplier

Air Purifier Manufacturer

Collagen  Mask Manufacturer

Beauty Device Manufacturer

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.

Hand Sanitizer Supplier

hand sanitizer

Peal-off Mud Mask Supplier

Disposable Face Mask Supplier

Surgical Mask Manufacturer

N95 Respirator Manufacturer

FFP2 Respirator Suppliers 

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.

Peal-off Mud Mask Supplier

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.

Hand Sanitizer Supplier

Automatic Hand Sanitizer Dispenser Supplier

Air Purifier Manufacturer

Collagen  Mask Manufacturer

Beauty Device Manufacturer

FFP2 respirator suppliers

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?

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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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.

Hand Sanitizer Supplier

Automatic Hand Sanitizer Dispenser Supplier

Air Purifier Manufacturer

Collagen  Mask Manufacturer

Beauty Device Manufacturer

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.

Peal-off Mud Mask Supplier

Disposable Face Mask Supplier

Surgical Mask Manufacturer

N95 Respirator Manufacturer

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!

Get help from RELIANCE B&H

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

Peal-off Mud Mask Supplier

Disposable Face Mask Supplier

Surgical Mask Manufacturer

N95 Respirator Manufacturer

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.

 

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Regulatory and standard information American buyers need to know when importing respirators (N95)

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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      Respirators (N95) For Medical Use

According to the FDA:

An N95 [standard] respirator is a respiratory protective device designed to achieve a very close facial fit and very efficient filtration of airborne particles.

They are a type of Filtering Face piece Respirator (FFR). Respirators do a similar job as medical masks, but in addition they protect the wearer from very small particles.

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A well-known label for them is ‘N95’ masks and they are so-called because their standard is to filter out 95% of 0.3 µm particles. However, ‘N’ is not the only designation.

In fact, we can see the following:

  • N= Not oil-resistant
  • R= somewhat oil-Resistant
  • P= oil-Proof
  • 95= 95% efficiency at 0.3 µm
  • 99= 99% efficiency at 0.3 µm
  • 100= 99.97% efficiency at 0.3 µm (this rating is equivalent to the HEPA filters used on products such as vacuum cleaners and air filtering machines or in automobiles).

In a healthcare setting, non oil-resistant masks are usually used, hence the focus on ‘N’ respirators during this pandemic.

 

FDA regulated under 21 CFR 878.4040

Like surgical masks, they are also FDA regulated under 21 CFR 878.4040 as class II medical devices (see part 3) because, in the case of respirators used specifically to protect against coronavirus, they are not exempt (respirators not used for health reasons will be exempt from 21 CFR 878.4040). So importers will be expected to provide detailed information about:

  • Identification
  • Classification
  • Analysis and Non-clinical testing (tests shown earlier)
  • Usability performance
  • Labeling requirements
  • Warning and precautions
  • N95 respirator manufacturer

Standards & Lab Tests specific to respirators: NIOSH and OSHA requirements

NIOSH

The difference between surgical masks and respirator production are the testing standards they must adhere to which fall under NIOSH, 42 CFR Part 84 Respiratory Protective Devices standard:

As per 42 CFR: “NIOSH will now have exclusive authority for testing and certification of respirators with the exception of certain mine emergency devices, which will continue to be jointly certified by NIOSH and MSHA.”

42 CFR 84 subpart K for Non-Powered Air-Purifying Particulate Respirators 

42 CFR 84 demands the following before approval can be granted:

  • Labeling
  • QC plans
  • Description
  • Required components
  • Inhalation and exhalation valve minimum requirements
  • Head harnesses; minimum requirements
  • Filter identification
  • (Test 1) Airflow resistance tests
  • (Test 2) Non-powered air-purifying particulate filter efficiency level determination
  • (Test 3) Exhalation valve leakage test

Respirator Lab Tests

There are three tests that need to be performed to meet testing requirements.

  • (Test 1) Airflow resistance tests
    The Inhalation and Exhalation Resistance testing is conducted to measure the breathability of the respirator. For NIOSH acceptance, the inhalation resistance cannot exceed 35 mm water column height pressure. For NIOSH acceptance, the exhalation resistance cannot exceed 25 mm water column height pressure.
  • (Test 2) Non-powered air-purifying particulate filter efficiency level determination
    The Sodium Chloride Aerosol testing is conducted to determine the percentage of particles filtered by the respirator. ≥95% filtration efficiency for N95 respirators.
  • (Test 3) Exhalation valve leakage test
    The Valve Leakage testing measures the amount of leakage between the valve and the valve seat. For NIOSH acceptance, the leakage between the valve and the valve seat cannot exceed 30 milliliters per minute.
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Watch this video about respirator certification from NIOSH: Respirator Certification – As Vital as the Air We Breathe

OSHA

It’s also useful for importers to understand how respirators are regulated by the Occupational Safety and Health Administration standard number 1910.134 – Respiratory Protection. This will show how employees in the USA who are exposed to airborne dangers should be equipped with a NIOSH-certified respirator to protect them by their employers.

 

Surgical N95 respirators are exempt from the 501(k) premarket notification if they are NIOSH (National Institute for Occupational Safety and Health) approved.

 

How does respirator filtration work?

This video from NIOSH can help explain mask filtration (especially in the case of N95 masks): A Particle is a Particle

Particles are trapped by masks in 3 ways:

  1. Impaction
  2. Interception
  3. Diffusion

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Physics dictates that 0.3 µm is the particle size which can pass most easily through materials like masks, they are just the right size to be small enough but have enough velocity. Therefore mask filtration is based on that size.

Larger sized particles are too large and will be trapped, and, perhaps surprisingly, smaller sized particles will also become trapped (filtered) as they are too small to have enough velocity to make it through the material.

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Regulatory and standard information American buyers need to know when importing surgical (medical) face mask

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 non oil-resistance and filtration percentage

Regulations common to both Medical Face Masks and Respirators, Surgical Mask manufacturer

  Surgical (Medical) Face Mask

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Surgical Mask Manufacturer

These masks are typically made from a papery material with 3, 4, or 5 ply thickness, and can be commonly seen being worn by hospital staff, for example surgeons performing operations, hence their name.

They are single-use and must be effective at:

  • Protecting the wearer from dangerous microorganisms, bodily fluids in the form of spray, splashes, or particles.
  • Protecting others from the above emitted by the wearer.
  • Surgical Mask manufacturer

They do not filter such a high proportion of the air as a respirator, however they offer far more protection for the wearer and others than going without a mask.

Surgical masks for the USA have the following information regarding classification and standards and must be FDA regulated under 21 CFR Section 878.4040: Surgical apparel.

According to the FDA, Surgical masks are class II medical devices, which means that they are:

“…devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns.”

Medical face mask performance testing requirements

There are 6 FDA-approved standards used in the production and testing of medical face masks summarized below:

 

There are 6 FDA-approved standards used in the production and testing of medical face masks summarized below:

 

  1. Particulate Penetration Test

ASTM F2299/F2299M-03(2017) Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres
Measures submicron particle filtration with the expectation that similarly-sized viruses will be similarly filtered. Particles ranging between 0.1-5 microns are suspended in an aerosol which is passed through the mask material and particles are counted should they pass through.
A penetration rating of PFE ≥ 95% or 98%@0.1 micron can be shown on mask packaging.

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  1. Bacterial Filtration Efficiency (BFE) Testing

ASTM F2101-19 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
Measures how well the mask filters out airborne bacteria. ASTM F2101-19 specifies drawing the biological aerosol through the medical face mask material and collecting aerosol droplets which penetrate the medical face mask material.
A filtration rating of BFE ≥ 95% or 98% can be shown on mask packaging.

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  1. Resistance To Blood/Fluids Testing

ASTM F1862/F1862M-17 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
Surgical masks are tested for their fluid resistance to blood, bodily fluids, or other infectious liquids using synthetic blood which is dispensed at high velocity using human blood pressure. How much ‘blood’ has permeated the mask is then assessed.
A resistance rating of Fluid resistance 80/120/160 mmHg can be shown on mask packaging.

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  1. Flammability Testing

US CPSC 16 CFR Part 1610 Standard for the Flammability of Clothing Textiles
As per ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks, face masks flammability should be tested in adherence with the US CPSC 16 CFR Part 1610: Standard for the Flammability of Clothing Textiles. Samples of the material are heated to assess how flammable they are and are given the following classifications (classes 1 & 2 are usually used in a surgical environment):

Mask packaging can include this information.

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  1. Differential Pressure Testing 

The FDA recommends that surgical masks (that are not NIOSH certified N95 Respirators) undergo differential pressure testing (Delta P) via this standard: MIL-M-36945C 4.4.1.1.1 Method 1 Military Specifications: Surgical Mask, disposable (June 12, 1975). Delta-P determines the resistance of the surgical facemask to air flowing through the mask which influences the breathability and comfort of the surgical mask. In general, a lower Delta-P translates to increased breathability.

  1. Skin Sensitivity Testing

The FDA also recommends that medical face masks be tested to an international standard (ISO 10993-5, 10) for skin sensitivity and cytotoxic tests as they are in prolonged contact with skin. Tests are conducted on materials used in construction of the mask which come in contact with the user’s skin.

 

Other standards relating to medical face masks

Read these standards to understand, in full, the FDA’s expectations:

Categorizing surgical (medical) face masks

Once all performance tests have been completed, it is possible to categorize the surgical mask into one of three levels based on the test results (Table source):

Importers of these face masks need to be aware of these classifications and standards in order to be assured that they’re bringing in safe products.

For the time being, ASTM is providing a free reading room of standards connected with the manufacturing and testing of PPE. You must sign up for a free account to access it and can do so here.

Other surgical (medical) face mask requirements from the FDA

The FDA also call for the following:

Product description

The importer will provide a description of the face masks, including:

  • Materials
  • Specifications and dimensions
  • Mask style
  • Design features
  • NIOSH certification number (when available)

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Learn more about this in section 5 of this FDA page.

 

Product labeling and warnings

According to FDA 21 CFR 801, correct face mask labeling includes:

  • Name and place of business of manufacturer, packer or distributor.
  • Meaning of intended uses.
  • Adequate directions for use.
  • Misleading statements.
  • Prominence of required label statements; use of symbols in labeling.
  • Spanish-language version of certain required statements.
  • Format of dates provided on a medical device label.

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Quality Management System

Surgical mask manufacturers are expected to conform with the Good manufacturing practice (GMP) by the FDA. In 21 CFR 820, they lay out their expectations for the manufacturer’s quality system which includes:

  • Quality policy.
  • Responsibility and authority.
  • Management representative.
  • Management review.
  • Quality planning.
  • Quality system procedures.

Essentially, PPE like surgical masks and respirators require a relevant and appropriate quality management system to be used by the manufacturer, and this is checked as part of FDA certification.

Surgical Mask manufacturer

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Announcement No.12 (2020) of the Ministry of Commerce, the General Administration of Customs, and the State Administration for Market Regulation on Further Enhancing Quality Oversight for Exported Epidemic Prevention and Control Supplies

In order to better support the international community’s joint response at this unusual moment towards a global public health crisis caused by the spreading COVID-19 pandemic, the measures to enhance quality oversight and step up export regulation for epidemic prevention and control supplies are announced as follows:

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I. Enhancing quality oversight for exported non-surgical face masks. As of April 26, 2020, exported non-medical use face masks shall conform with the quality standards of China or other countries.

The Ministry of Commerce shall offer a list of validated non-medical use face mask manufacturers with certification or authorization from other countries (see www.cccmhpie.org.cn for updates). The State Administration for Market Regulation shall provide a list of disqualified non-medical use face masks and manufacturers found on the Chinese market (see www.samr.gov.cn for updates). Exporting companies of non-medical use face masks shall submit a joint declaration of the exporter and the importer (see Annex 1) in writing or in electronic form together with customs declarations, as a confirmation that the products are compliant with the quality standards of China or other countries, and that the importer accepts the quality standards of the products purchased and does not use them for medical purposes. The customs shall inspect and release products according to the list provided by the Ministry of Commerce; for products from manufacturers not included in the list of the State Administration of Market Regulation, the customs shall accept the declarations, and inspect and release the products.

The joint declaration of the exporter and the importer (see Annex 1) shall be submitted in writing or in electronic form together with the export customs declarations under purchasing contracts signed before April 26, 2020.

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II. Stepping up export regulation for medical supplies. As of April 26, 2020, exporting companies of SARS-CoV-2 testing reagents, medical face masks, medical protective suits, ventilators and infrared thermometers that have obtained certification or authorization from other countries shall submit a declaration (see Annex 2) in writing together with customs declarations, as a warranty that the products are compliant with the quality standards and safety requirements of the importing countries (regions). The customs shall inspect and release products according to the list of manufacturers that have obtained certification or authorization from foreign countries (see www.cccmhpie.org.cn for updates) offered by the Ministry of Commerce.

The above measures shall be adjusted as the pandemic progresses.