Definitions and Requirements
- This device is a face shield for Medical, Industrial, or Personal use intended to be worn to over the face, and sides of the face with the padded foam strip contacting the users forehead.
- This product is intended for either single use or multiple use by the same user. The user may clean the mask by completely wiping both surfaces with cleaning and disinfecting agents such as bleach germicidal cleaner, or 99% isopropyl alcohol.
- This is a standalone face shield and is not integrated with any other Personal Protective Equipment (PPE) in itself. It may be incorporated with other forms of PPE the user may or may not be required to wear (Glasses, masks, etc.). The user assumes responsibility for use with other equipment.
- It is recommended to not be used in the presence of high intensity heat sources or flammable gas or open flames.
- This shield will not in itself prevent infection from microbes or viruses or radiation protection. It is intended and may prevent Health Care Providers (HCP) from exposure to certain particulates by providing low barrier protection to the wearer.
- This shield is manufactured in accordance with the FDA guidelines under the Emergency Use Authorization (EUA) dated 4/13/2020.
This Summary was developed using the guidelines addressed in: https://www.fda.gov/media/136842/download