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Approved and certified by FDA, ISO 13485, CE Certificate, Medical Regulatory Bodies. Package: 50 PIECES / 1 Packet / 50 Packets / 1 Carton Remark: This Face Mask is ideal for Hospitals, Schools, Food handling and services . and can be used in any hazard or dusty environment. It is also recommended for personal useFDA Issues Enforcement Policies for Face Masks and , iso ce fda approved medical use face maskMar 27, 2020 · FDA is allowing the distribution and use of certain medical device requirements for FDA-regulated face masks, with or without a face shield (not including respirators), face shields and surgical masks if manufacturers and distributors implement defined measures to prevent undue risks. FDA will not enforce premarket notification (510k), registration and listing, quality system regulation Surgical Masks - U.S. Food and Drug AdministrationThe surgical masks referenced in this guidance document include masks that are labeled as a surgical, laser, isolation, dental or medical procedure masks with or without a face shield.

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