• The product has not been FDA cleared or approved
• The product has been authorized by FDA under a EUA for use as source control by the public as well as by HCP in healthcare settings 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 -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.
Not recommended for use in any surgical setting or where significant exposure to liquid, bodily, or other hazardous fluids may be expected, or use in a clinical setting where the infection risk level through inhalation exposure is high or use in the presence of a high-intensity heat source or flammable gas.
The masks are manufactured in China for Alira Medical Devices, an FDA-registered company located in Los Angeles California, USA.