DUAL-LAYER FACE COVER

*The insert has been shown by a third-party testing facility to block up to 97% of 3-micron-sized non-viable particles and 0.1-micron-sized aerosolized particles

WARNING: The product has not been FDA cleared or approved. 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. Source control refers to the use of a face mask over the mouth and nose to contain that individual’s respiratory secretions to help prevent transmission from infected individuals who may or may not have symptoms of COVID-19. 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. The face mask is intended to be used with single-use inserts. There has not been testing of the effectiveness of the disposable insert when placed in the mask. Accordingly, this product is not a respiratory protective device, nor a substitute for filtering face piece respirators or for surgical face masks. This product is not for medical use or for use in a high infection risk clinical setting. It is not intended to be used to provide liquid barrier protection or for high-risk aerosol generating procedures.