The face cover should not be used (1) in a surgical or medical setting where significant exposure to liquid, bodily or other hazardous fluids, may be expected; (2) in a clinical setting where the infection risk level through inhalation exposure is high; or (3) in the presence of a high intensity heat source or flammable gas.
This product is not intended for antimicrobial or antiviral protection or related uses or for use such as infection prevention or reduction. This product is not a respiratory protective device, and therefore should not be used for particulate filtration. This product is not intended for use in high risk aerosol generating procedures. This product is not a replacement for medical grade protective equipment. Sol and Selene Inc. makes no warranties, either express or implied, that the face cover prevents infection or the transmission of pathogens, viruses or diseases.
The product has 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. The product has not been FDA cleared or approved. This product 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.