User Guide

This device has been authorized by FDA under an Emergency Use Authorization (EUA) for use by a healthcare provider (HCP) as personal protective equipment, and 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. This device 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 is not manufactured in compliance with 21 CFR Part 820, ISO 13485, or similar Quality Management System regulations.

• MasksOn Reusable Face Mask may ONLY be used when FDA cleared masks are unavailable
• MasksOn Reusable Face Mask is NOT recommended for use in a surgical setting or where significant exposure to liquid bodily or other hazardous fluids may be expected
• MasksOn Reusable Face Mask makes NO claims of antimicrobial or antiviral protection
• MasksOn Reusable Face Mask makes NO claims of infection prevention or reduction
• MasksOn Reusable Face Mask makes NO claims regarding flammability
• MasksOn Reusable Face Mask is intended for multiple uses by the same user.