These products have not been FDA cleared or approved, but have been authorized by FDA under an Emergency Use Authorization (EUA) for use as source control by the general public and by health care providers in healthcare settings as to help slow the spread of infection or illness during the COVID-19 pandemic.
These products are:
- not intended for use as a surgical mask or to provide liquid barrier protection;
- not recommended for use in a clinical setting where the risk of infection through inhalation is high;
- not intended for antimicrobial or antiviral protection or related uses;
- not intended for infection prevention or reduction;
- not a respiratory protective device and should not be used for particulate filtration;
- not for use in high risk aerosol generating procedures.
These products shall remain authorized for such uses only for the duration of the FDA’s declaration, under section 564(b)(1) of the Federal, Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), that circumstances exist justifying the emergency use of medical devices, unless the EUA is terminated or revoked sooner. The spread of COVID-19 can be reduced when cloth face coverings are used along with other preventive measures, including social distancing, frequent handwashing, and cleaning and disinfecting frequently touched surfaces.