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Jun 15, 2020 · Surgical mask manufacturers or importers are required to submit a 510(k) premarket notification to gain the FDAs 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):Medical Disposable Surgical Masks (Face Masks) | FDAApproved by CE & FDA Please Note: Face masks do not eliminate the risk of exposure, infection, illness or death. Maintain a healthy respiratory system with the 3 Ply Personal Protective Disposable Face Mask (100 Pack), helping you breathe easier by keeping you safe from dust, bacteria and potentially harmful substancesN95 Respirators, Surgical Masks, and Face Masks | FDAN95 respirators, surgical masks, and face masks are examples of personal protective equipment that are used to protect the wearer from airborne particles and from liquid contaminating the face.

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