This face mask product is designed to withstand multiple washes, and when used with a disposable insert provides the wearer with an extra layer of mouth and nose coverage beyond a common cloth face covering.
The filter 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 (Food and Drug Administration) cleared or approved. The face mask has been authorized by FDA under an Emergency Use Authorization for use as source control by the general public as well as by healthcare personnel 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. There has not been testing of the effectiveness of the disposable insert when placed in the Face Mask. Accordingly, the Face Mask 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 a surgical mask and is not intended to be used to provide liquid barrier protection or for high-risk aerosol generating procedures. The face mask 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 Federal, Food, Drug, and Cosmetic Act, 21 U.S.C. 360bbb-3(b)(1) unless the authorization is terminated or revoked sooner. This product has not been tested against COVID-19.
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