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N95 Respirators and Surgical Masks (Face Masks) | FDA

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FAQs on Shortages of Surgical Masks and Gowns | FDA

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FDA reviews and clears surgical masks under 21 CFR 878.4040 as Class II medical devices, which may be labeled as surgical masks, surgical masks with an antimicrobial/antiviral agent, or pediatric , protective face mask disposable medical mask surgical face mask

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