Disney Face Mask – Frozen – Anna & Elsa

Disclaimer: This Disney cloth face mask is not a surgical face mask which provides liquid barrier protection. This cloth face mask should not be used (1) in a clinical setting where the infection risk level through inhalation exposure is high; (2) for antimicrobial or antiviral protection or related uses or uses for infection prevention or reduction or related uses; (3) as a respiratory protective device, or (4) for high risk aerosol-generating procedures. Disney makes no warranties, either express or implied, that the face mask prevents infection or the transmission of viruses or diseases.

The product has not been FDA cleared or approved

The product has been authorized by FDA under an EUA for use as source control by the general public as well as by HCP in healthcare settings as 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 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.