Authorized Face Shields
Face shields for use by HCP as PPE are authorized under this EUA when they are intended for use by HCP as PPE in healthcare settings in accordance with CDC recommendations to cover the front and sides of the face and provide barrier protection and meet the following requirements:
A. The product is labeled accurately to describe the product as a face shield for medical purposes and includes a list of the body contacting materials (which does not include any drugs or biologics);
B. The product is not integrated with any other article of PPE such as a face mask, but rather is for use as a standalone face shield.
C. The product includes labeling that describes the product as intended for either a singleuser, single use, or for multiple uses by the same user, and includes instructions for recommended cleaning and/or disinfection materials and processes, if applicable.
D. The face shield does not contain any materials that will cause flammability, or the product meets Class I or Class II flammability requirement per 16 CFR 1610 (unless labeled with a recommendation against use in the presence of high intensity heat source or flammable gas);
E. The product is not intended for any use that would create an undue risk in light of the public health emergency; for example, the labeling does not state that use of the authorized face shield alone will prevent infection from microbes or viruses, or that it is effective against radiation protection. As indicated in Section I, face shields authorized by this EUA may be effective at preventing HCP exposure to certain particulates during face shield shortages by providing minimal or low barrier HCP protection to the wearer during COVID-19