Guidance on regulatory requirements for face masks manufacturers in the US
You are planning to launch your production line of face masks and you are seeking information about regulations, marking, or any other requirements to operate your activity in the US. Here is MKEnX's guide from our advisers to provide you with the relevant information.
The US regulations about face masks are divided into medical (medical masks) and industrial (respirators) use.
Medical face masks protect the wearer’s face from contact with body fluids, bacteria and various particles.
Medical face masks are considered as medical devices and regulated by the medical device regulations of the US. Such regulations define the legal obligations in order to ensure that medical face masks will provide the minimum level of protection against intended risks. Specific requirements by classification are cited in the referenced performance standard.
In the regulations of the US, medical masks and medical surgical masks are differentiated.
Classified as either a Class 1 or Class 2 medical device, in the US medical masks must meet the labelling requirements of the relevant regulations. Some medical masks may be classified as “source control” per Emergency Use Authorization.
Designed to provide the wearer with respiratory protection against inhalation of a hazardous atmosphere, respirators are designed for the efficient filtration of airborne particles.
Respirator regulations are the jurisdiction of the FDA, and define the legal obligations to ensure that respirators provide the minimum level of protection against intended risks. Specific requirements by classification will be contained within regulation or cited in referenced performance standard.
In the regulations of the US, respirators and surgical respirators are differentiated.
● The National Institute for Occupational Safety and Health (NIOSH) specifies minimum approval requirements for respiratory protective devices in Title 42 Code of Federal Regulations (CFR) Part 84.
● NIOSH approval labels are described in 42CFR84 (§84.33), and the information they provide, and their locations differ depending on the respirator type. These labels are referred to as “entire” or “abbreviated” (§84.33[e]). However, these labels do not identify the approved respirator’s complete configuration of components.
- Regulation 21 CFR Subchapter H, Regulation for Medical Devices
- ASTM F2100-19, Standard Specification for Performance of Materials Used in Medical Face Masks
- ASTM F2100, Respirator Approval Information
- FDA 21 CFR 878.4040, Regulation for Surgical Devices
- ASTM F1862, Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (paid standard)
- 16 CFR 1610, Standard for the Flammability of Clothing Textiles
- OSHA 29 CFR1910.134, Regulation for Respiratory Protection
- NIOSH:42 CFR 84, Approval of Respiratory Protective Devices
COVID-19 Regulatory Updates
- Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency
- Emergency Use Authorization for Source Control Face Masks
- Emergency Use Authorization for Personal Protective Equipment (Respirators)
- FDA FAQ: Face Masks, including Surgical Masks, and Respirators for Covid-19