The United States has access requirements for face masks and other anti-epidemic products
Surgical masks are regulated by the food and drug administration, while personal respirators are regulated by the national institute of occupational safety and health.
1. Surgical mask
Surgical masks must be registered with the FDA, and the company shall apply directly to the FDA website and submit relevant materials.
There are two other options:
(1) N95 masks registered with NIOSH may be exempted from the marketing registration (510K), FDA factory registration and medical device listing if the product has passed the biological test, flame retardant test and blood penetration test.
(2) if authorized by the manufacturer holding 510K, the 510K approval number can be used as its OEM for enterprise registration and device listing.
2. Personal protective mask
Respirators must be registered by NIOSH. Apply directly from the NIOSH website.
(2) protective clothing
The regulation of medical and personal protective clothing, which is regulated by the food and drug administration and personal protective clothing by the national institute of occupational safety and health, is similar to the regulation of masks.
Businesses register directly with the FDA or NIOSH.