This document is made available by Temple University for informational and educational purposes only and does not constitute legal or medical advice regarding the design, manufacture, or use of face shields.
Face shields may constitute a class I medical device when used in certain healthcare settings. This product has NOT been FDA cleared or approved. Manufacture of this product may be authorized by FDA under an Emergency Use Authorization (“EUA”) letter for use by healthcare providers as personal protective equipment, see https://www.fda.gov/media/136842/download. If produced in accordance with the EUA, 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.
This device should NOT be used as a replacement for conventional and approved Personal Protective Equipment (PPE) when available. Use of these face shields alone will NOT prevent infection from microbes or viruses, including COVID-19. This device has not been industry tested nor has it been NIOSH approved.
These face shields have been designed by Temple University for low impact use to protect the user’s eyes and face from bodily fluids, liquid splashes, or potentially infectious materials. These face shields were designed for multi-use by a single provider, however, users should exercise caution and clean the face shields after each use. Manufacturers and users are solely responsible for any and all risks associated with production, use, and cleaning of face shields. THIS PRODUCT DESIGN AND RELATED INFORMATION IS MADE AVAILABLE AS-IS, AND TEMPLE UNIVERSITY EXPRESSLY DISCLAIMS, ANY WARRANTY, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION THE WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, AND NONINFRINGEMENT. Reference to any particular product brand name or materials does not constitute an endorsement, guarantee, or representation by Temple University.