The Premier Guard USA (“PGUSA”) Surgical Face Mask is a disposable, single-use surgical mask consisting of 3-ply polypropylene materials, a nose wire, and elastic earl oops that does not contain natural rubber latex, any drugs, biologics, nanoparticles, or antimicrobial/antiviral agents.
The product is not intended to replace the need for FDA-cleared surgical masks or FDA-cleared or authorized respirators.
In addition, the PGUSA Surgical Face Mask is not intended to provide protection against pathogenic biological airborne particulates and is not recommended for use in aerosol generating procedures and any clinical conditions where there is significant risk of infection through inhalation exposure; and
The PGUSA product has not been FDA cleared or approved.
Rather, it has been authorized by the FDA under an EUA for use in healthcare settings by HCP as PPE to provide a physical barrier to fluids and particulate materials to prevent HCP exposure to respiratory droplets and large particles during surgical mask shortages resulting from 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.