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Face Masks and N95 Respirators Not Intended for a Medical Purpose Face masks and N95 respirators are deviceswhen they meet the definition of a device set forth insection 201(h) of the FD&C Act. Under section 201(h) of the FD&C Act, these products are devices whenthey are intended for use in the diagnosis of disease or other conditions or in the ...

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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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