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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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.

Surgical Mask manufacturer

 

  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.

Surgical Mask manufacturer

 

  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.

Surgical Mask manufacturer

 

  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.

Surgical Mask manufacturer

 

  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)

Surgical Mask manufacturer

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.