FDA Emergency Use Authorization
As required by the April 13, 2020 letter from FDA to Manufacturers of Face Shields, each Face Shield should include the following documentation:
- This face shield has not been FDA cleared or FDA approved but rather has been authorized by FDA under an Emergency Use Authorization (EUA) for use by healthcare providers (HCP) as personal protective equipment (PPE) in healthcare settings in accordance with CDC recommendations to provide barrier protection to the front and sides of the face.
- This face shield is a standalone device that may be used for medical purposes.
- This face shield includes these body contacting materials:
- Nylon Hook & Loop (Loop is body contacting)
- Polyurethane Foam
- This product does not prevent infection from microbes or viruses but may be effective at preventing HCP exposure to certain particulates.
- This product is not for use in the presence of a high intensity heat source or flammable gas. Do not expose to open flame.
- This face shield is intended for multiple uses by a single user provided it is cleaned per these instructions:
- Spray or rinse the entire device in cleaning agent, allow to air dry and wipe shield portion clear with a moistened towel. Recommended cleaning agents include warm water & soap, 70% isopropyl alcohol or 3-4% Hydrogen Peroxide.
- Report complaints to the manufacturer by email, phone or in person:
- Email: firstname.lastname@example.org
- Phone: 901-543-8525 ext. 1
- 769 Vance Avenue, Memphis, TN 38126
- This product is only authorized for the duration of the declaration that circumstances justifying the authorization of emergency use under Section 564 (b)(1) of the Act, 21 USC 360bbb-3(b)(1) unless the authorization is terminated or revoked sooner.
- Face Shield is made from clear PETG.