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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 ...

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Technical Requirements for Medical Surgical Masks; FDA certification CE0197 certification ; ISO13485 international quality management system certification. A medical surgical mask is a mask worn by medical staff when working. It is mainly used in high-demand medical environments such as medical clinics, laboratories, and operating rooms.

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