WARNING: This face mask 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. 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 the HEPA filter inserts. This product, which is not for medical use or for use in a high infection risk clinical setting, is not a respiratory protective device, nor a substitute for Filtering Facepiece Respirators or for surgical face masks. It is not intended to be used to provide liquid barrier protection or for high-risk aerosol generating procedures.

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