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N95 Respirators and Surgical Masks (Face Masks) | FDA

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A standard N95 respirator is a tight-fitting respiratory protective face mask, designed to help reduce the user’s exposure to airborne particles including very small particles (0.3 microns) and large droplets. N95 respirator face mask literally has a filtration efficiency of at least 95% against non-oily particles.

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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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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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