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The FDA's Role in Regulating Personal Protective Equipment

Updated: Sep 13, 2020

All of our personal protective equipment (PPE) follow FDA regulations and follow the standards approved for protection. This includes surgical masks, N95 respirators, medical gloves, and gowns. The FDA requirements and approved standards vary depending on the type of PPE item. Our items fully comply with the approved standards and FDA regulations needed and are therefore safe and effective.

Some PPE products are reviewed by the FDA before they are legally sold in the United States. The Premarket Notification or 510(k) clearance, shows that manufacturers must demonstrate that they meet specific criteria regarding labeling, substantial equivalence, and performance. One way that substantial equivalence can be shown is by exceeding approved standards for barrier performance and resistance to snags and tears. Approved consensus standards may also be used to demonstrate sterility, biocompatibility, resistance to fluids, and flammability. Manufacturers must ensure the methods to test conformance to standards are valid and support each product with reliable performance test data.


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