This product is intended to be used for the prevention of disease by limiting transmission, however, it is not an FDA-cleared medical device and is being manufactured pursuant to the FDA Guidance Document on PPE April 2020 – Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency. Materials are not flame resistant.

As per the CDC do not adjust to fit children younger than 2 years of age, anyone who has trouble breathing, or is unconscious, incapacitated or otherwise unable to remove the cover without assistance.