Airpro PPE
WARNINGS
- The product has not been approved by the FDA.
- The product has been cleared by the FDA under a EUA for use by HCP as PPE to help prevent the spread of infection or disease in healthcare settings and by the general public to help slow the spread of the virus. during the COVID-19 pandemic.
- This product is licensed only for the duration of the statement that circumstances exist that justify 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 USC § 360bbb-3 (b) (1) unless the authorization is terminated or revoked earlier.