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Oct 15, 2009 · The FDA has no role in the approval or clearance of N95 respirators not intended for use as a medical device. View a table of Surgical N95s which is provided as a courtesy. If you have a product that you believe is FDA cleared that does not appear on this table, you should verify the FDA clearance by contacting the FDA at 1-800-638-2041.The Basics of Surgical Mask Selection | Infection Control , sterile fda approved shield 3 ply fda medical use grade maskA surgical mask is an example of an article regulated as a medical device. NIOSH. The National Institute for Occupational Safety and Health (NIOSH) is a federal agency and branch of the Department of Health and Human Services whose function is to identify substances that pose potential health problems and recommends exposure limits to OSHA.FDA Surgical MaskN95 masks are considered a medical device and are regulated by the U.S. Food and Drug Administration. You can see a list of FDA-approved masks here. You might see people wearing surgical masks. Get Price; Personal Protective Equipment for Infection Control FDA. The FDA"s role in regulating personal protective equipment.

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