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:
- Surgical face mask (medical face mask)– vary from 3 to 5 ply thickness
- 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:
- 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
- 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
- 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
- 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
- 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.
- 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:
- ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks
- ASTM F1494-14 Standard Terminology Relating to Protective Clothing
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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