On this page, we’re collecting information about face mask and respirator regulations and standards that importers need to be aware of when importing face masks from China to the USA (and Canada which shares many import regulations).

Last updated: 6/15/20 (FAQ related to relaxed requirements)

Importing Face Masks from China to the USA

Regulatory and standard information American buyers need to know when importing face masks

Face masks used for protection during the Coronavirus pandemic, and in any healthcare setting, belong to the product category of ‘disposable medical PPE.’

Table of contents

We can generally categorize PPE face masks 2 ways, hit the links to travel to the section you’re interested in:

  1. Medical face masks (surgical masks) – vary from 3 to 5 ply thickness
  2. Respirators – vary based on oil-resistance and filtration percentage
  3. Regulations common to both Medical Face Masks and Respirators
  4. FAQs – answering some questions that may come to mind

Medical (Surgical) Face Masks

surgical face masks commonly imported into the USA from China

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.

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 summarised 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.

2. 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.

3. 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.

4. 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):

surgical mask flammability classes
Mask packaging can include this information.

5. 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 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.

6. 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 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):

surgical mask levels

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 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)

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.
  • Definitions.
  • 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.

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

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

Respirators (N95) For Medical Use

surgical FFR respirator commonly imported into the USA from China

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 Facepiece Respirator (FFR). Respirators do a similar job as medical masks, but in addition they protect the wearer from very small particles. 

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

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


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 NIOSH 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.

Watch this video about respirator certification from NIOSH: Respirator Certification – As Vital as the Air We Breathe


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.

How should NIOSH-approved respirators be labeled?

According to the CDC, compliant respirators will be labeled as follows (this is important to note for importers, as any deviation from this is a ‘red flag‘ to be cautious of, as it may indicate that your supplier and/or the products themselves are not legitimate and could be unsafe for use):

NIOSH respirator labeling

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

Physics dictates that 0.3 µm is the particle size that 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.

Regulations Common To Both Face Masks & Respirators

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 chages 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

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. 

Important points for importers to check medical device veracity

All foreign manufacturers of medical devices are required to have a representative with a real address in the U.S. and somebody available during business hours; effectively, a US agent. But recently a loophole has come to light, over 1,300 Chinese suppliers of medical products have used bogus registration data with a false address (shared by them all) and telephone number that does not work.

This doesn’t speak well for the legitimacy and safety of the products.

You can read more about this in this article from the WSJ (paywall).

How to stay safe?

Here are some tips that importers should follow to assure that the devices are compliant and safe:

1. If the devices are class II, the seller needs FDA approval, not just FDA registration.

2. If registration is sufficient, check the exact product class and confirm it is the right one.

3. If registration is sufficient, request details about the US-based agent listed on the registration.

USA Face Mask & Respirator Importing FAQs

In general, there have been some relaxations in rules in order to encourage a better supply of surgical masks and respirators during the coronavirus pandemic, however, this advice has changed a lot since March 2020.

Read on for information which is up to date as of May 26th 2020.


N95 respirators (FFRs)

According to the FDA, FDA-cleared or NIOSH Approved N95 respirators should be used if at all possible. Respirators from other sources, such as KN95 respirators from China, may be used if the device meets the applicable EUA’s demands.

Regarding the possible use of non-NIOSH approved or FDA-cleared FFRs, 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.”

Note that as of May 7th 2020, this list of authorized non-NIOSH approved respirator manufacturers has been cut from around 80 to just 14 due to ongoing quality issues where KN95 masks that have reached the USA have not reached minimum safety standards, i.e. did not filter at least 95% of particles from the air.

The FDA has issued a number of Emergency Use Authorization letters (EUAs) regarding respirators which you can read below:

Here is an excerpt from the EUA for China-made FFRs which are FDA-cleared for use:

A disposable non-NIOSH-approved respirator manufactured in China is authorized under this EUA if it meets any of the criteria below.
1. The respirator is manufactured by an entity that holds one or more NIOSH approvals, that have been verified by FDA, for FFRs, and that are produced by the NIOSH approval holder in accordance with the applicable standards of authorization in another country.
2. The respirator:
a. Has a registration certification, reflecting regulatory authorization, under the jurisdiction of the Chinese National Medical Products Administration (NMPA)
and that is given by an appropriate provincial or municipal authority, and that has been authenticated and verified by FDA, or
b. Conforms to Personal Protective Equipment (PPE) Directive 89/686/EEC (for those placed into distribution before April 21, 2019) or that conforms to PPE Regulation (European Union (EU)) 2016/425 (for those placed into distribution
after April 21, 2019), as evidenced by a CE mark, and the CE mark has been authenticated and verified by FDA.
3. The respirator was previously listed in Appendix A under the April 3, 2020 letter of authorization as an authorized respirator because it demonstrated acceptable performance to applicable standards as documented by test reports, has had particulate
filtration efficiency assessed by NIOSH using a modified version of NIOSH’s Standard Test Procedure (STP) TEB-APR-STP-0059 within 45 calendar days of the date of issuance of the May 7, 2020 letter, and has results of NIOSH testing that indicate a
minimum and maximum filtration efficiency greater than or equal to 95 percent.
A respirator authorized under this EUA because it meets the criterion in the previous sentence is no longer authorized if it has been sampled by FDA, tested by NIOSH via a modified version of STP TEB-APR-STP-0059, and has results according to NIOSH that indicates one or more of the 30 sampled respirators has a filtration efficiency of less than 95%.

Additional clarification has now been provided in the May 26, 2020, revision of “Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised).” The guidance now states that greater oversight will be given by the FDA for respirators that are not FDA cleared or authorized.

In the case of alternative respirators which do NOT reach the FFR EUA’s requirements, they may still be used as a face mask by the general public or healthcare professionals when certain criteria are met under the EUA for face masks instead.

  • The May 26th 2020 Guidance document can be found here.


Face Masks

Here is the FDA EUA for face masks:

Medical Face Masks (non-liquid barrier)

For the duration of this 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 of Corrections and Removals in 21 CFR Part 806, and Unique Device Identification requirements in 21 CFR Part 830 and 21 CFR 801.20 are not required and the FDA currently believes such devices would not create such an undue risk where:

  • The product’s labelling accurately describes it only as a face mask (NOT surgical mask or FFR respirator mask) and includes a list of materials that come into contact with the wearer’s face.
  • The labelling warns against use in any surgical setting, where significant exposure to liquid, bodily or other hazardous fluids is possible, in a clinical setting where the infection risk level is high, and where heat may cause the mask to burn.
  • The labelling may make no claims of providing protection for the wearer against viral infection or filtration of the air that they breathe.

Surgical Masks (Liquid barrier)

The FDA does not intend to object to the distribution and use of surgical masks 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 of Corrections and Removals in 21 CFR Part 806, and Unique Device Identification requirements in 21 CFR Part 830 and 21 CFR 801.20. FDA currently believes such devices would not create such an undue risk where:

  • The product meets fluid resistance testing (liquid barrier performance) consistent with standard ASTM F1862 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity).
  • The product meets Class I or Class II flammability requirement per 16 CFR 1610 (unless labelled with a recommendation against use in the presence of high-intensity heat source or flammable gas).
  • The product includes labelling that accurately describes the product as a surgical mask and includes a list of the body contacting materials (which does not include anything that may cause irritation or illness).
  • The product is not intended for any use that would create an undue risk in light of the public health emergency, for example, the labelling does not include uses for antimicrobial or antiviral protection or related uses or uses for infection prevention or reduction or related uses and does not include particulate filtration claims.


What happens after the coronavirus crisis subsides?

These changes are no doubt temporary, so PPE suppliers looking to export to the USA long-term should follow the instructions about becoming NIOSH & FDA certified. If you have purchased a lot of unregulated PPE during the crisis and continue to sell it afterwards, this could lead to problems with the authorities.

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.

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.

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.

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.

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!

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.

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.

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

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.

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.

  • Masks for protecting yourself from the virus are QKR.
    medical face mask classification
  • Surgical mask for protecting others (environment, patient) are FXX and OUK.

It may also be that your supplier offers you woven ‘barrier masks.’

A barrier mask, also known as a DIY mask, can be used to provide the wearer and others with some protection against coronavirus infection and is made from fabric. They can be washed and reused.

woven barrier mask

(Image Source)

Many cities and states are already advising or mandating that masks should be worn by the general public, for instance, Laredo, Texas. Therefore, to lower the impact on precious supplies of medical-use masks, masks for non-medical use like these are a good alternative, and the CDC has even suggested people make DIY masks and provided guidance on how to do so

Note, though, that these masks are not within the scope of MD or PPE and do NOT conform with the FDA and NIOSH standards they are regulated by. So you MUST NOT import and sell these as protecting against coronavirus infection or for use for medical professionals.

The FDA has released a memo related to ‘source control’ where they clarify that any non-medical use or non-PPE mask or face covering (such as a bandana or scarf) is classified as a control mask and cannot be advertised as protection against illnesses such as coronavirus.

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

  • Due diligence on suppliers before 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.

Yes, NIOSH is updating these pages with scam vendors:

However, carrying out your own due diligence on potential suppliers and products is the safest way to be sure of safety and compliance.

A respirator is a mask covering the nose and mouth which reduces the wearer’s risk of inhaling hazardous airborne particles (including infectious agents like coronavirus), gases or vapors by filtering the air breathed by the wearer. Respirators, including those intended for use in healthcare settings, are a form of PPE which is certified by the CDC/NIOSH.

Respirators are not surgical masks which are medical devices.

The CDC states:

An N95 respirator with an exhalation valve does provide the same level of protection to the wearer as one that does not have a valve. The presence of an exhalation valve reduces exhalation resistance, which makes it easier to breathe (exhale). Some users feel that a respirator with an exhalation valve keeps the face cooler and reduces moisture build-up inside the facepiece. However, respirators with exhalation valves should not be used in situations where a sterile field must be maintained (e.g., during an invasive procedure in an operating or procedure room) because the exhalation valve allows unfiltered exhaled air to escape into the sterile field.

In the USA the National Personal Protective Technology Laboratory (NPPTL) has recently carried out independent tests on non-NIOSH approved respirator masks from China to assess their efficiency and safety.

They used a modified version of NIOSH Standard Test Procedure (STP) TEB-APR-STP-0059 to test the particulate filtration efficiency of KN95 masks.

You can read the results here.

Check if your supplier is on this list or if you have unfortunately received counterfeit masks that are not effective.

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, too!

Sofeast’s indemnity and notes for the reader

  1. We are not legal professionals and any information provided here about the regulations and standards is only given for your reference. We do not accept responsibility for any issues you may face after using this information.
    If you are unsure about the validity of your face masks, please refer to the CDC or NIOSH or a local legal professional for assurance
    before importing face masks from China to the USA.
  2. This page will be updated periodically as we find useful new information. If you have a suggestion for a change or an addition, please contact us.

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