Is this mask certified?
– The product has not been FDA cleared or approved.
-The product has been authorized by FDA under an EUA* for use by HCP as PPE to help prevent the spread of infection or illness in healthcare settings and by the general public to help slow the spread of the virus during the COVID19 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.
*FDA Emergency Use Authorization dated 4/20/2018 Required Notice
How do I wear this mask?
WASH YOUR HANDS BEFORE HANDLING THE MASK.
- Hold the mask on the top and bottom and pop it open quickly with a little force.
- Once open, pull both sides to expand. Position the mask over the face, covering the nose and mouth.
- Pull elastic up and over your head.
- Pull down the edge of the mask, so that it fully covers the chin.
How often should I change my mask?
We recommend replacing the mask every 4 to 6 hours for optimum performance. This mask is disposable and should not be washed for reuse.