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Jun 16, 2020 · Further, some face masks require cleanroom rated materials which will not shed lint or fibers. Does the FDA Regulate N95 Masks? The FDA regulates products such as surgical N95 respirators and surgical-grade gowns. (Considered medical devices). Masks and PPE for non-medical purposes are not medical devices and are not regulated by the FDA. Face Masks and Surgical Masks for COVID-19:Answers to frequently asked questions about face masks and surgical masks, including manufacturing, purchasing, importing, and donating masks during the COVID-19 public health emergency.

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