Single-use face masks from Fairfield PPE provide soft and comfortable protection from germs, dust, and debris.
In accordance with the Emergency Use Authorization dated April 24-2020, this product shall not be used as a surgical mask or to provide liquid barrier protection. This product shall not be used in a clinical setting where the infection risk level through inhalation exposure is high.
The product has not been FDA cleared or approved;
The product has been authorized by FDA under an Emergency Use Authorization (EUA) for use as PPE in healthcare settings by HCP as they may help protect HCP and/or patients from the transfer of the SARS-CoV-2 virus in low or minimal risk level situations to prevent the spread of COVID-19.
This product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of medical devices, including alternative products used as medical devices, due to shortages during the COVID-19 outbreak, under Section 564(b)(1) of the Act, 21 USC 360bbb-3(b)(1) unless the authorization is terminated or revoked sooner.