Disclaimer: är Facemask has not been FDA cleared or approved. It has, however, been authorized by FDA under an EUA for use as source control by the general public as well as by HCP in healthcare settings as to help prevent the spread of infection or illness during the COVID-19 pandemic. It is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of medical devices, including alternative products used as medical devices, during the COVID-19 outbreak, under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1) unless the authorization is terminated or revoked sooner.
Disclaimer: är Gloves have not been FDA cleared or approved. Never use är Gloves in place of FDA-cleared surgeon’s gloves. This product is not intended for any use that would create an undue risk in light of the current public health emergency, and should not be used for antimicrobial or antiviral protection, nor for infection prevention or reduction.