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N95 Respirators and Surgical Masks (Face Masks) | FDA
2020-5-3 · N95 respirators and surgical masks (face masks) are examples of personal protective equipment that are used to protect the wearer from airborne particles and from liquid contaminating the face.
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2 天前 · Wash your hands after handling the used mask. The CE has 3 levels of certification – FFP1, FFP2 and FFP3. Our surgical masks are certified as FFP1. See more about Face mask protection in the resources below: medical expo. crosstex list of ASTM/CE levels. FDA COVID-19 Guidelines . Beware of fakes/non-certified masks:
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2020-4-26 · All personal protective equipment (PPE) that is intended for use as a medical device must follow The FDA's regulations and should meet applicable voluntary consensus standards for protection.
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Surgical Masks - Premarket Notification [510(k ...
2020-2-15 · This guidance supersedes “Draft Guidance for Industry and FDA Reviewers on the Content and Format of Premarket Notification [510(k)] Submissions for Surgical Mask” issued January 16, 1998.
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