Nov 8, 2023 · Q: Which face masks, barrier face coverings, and surgical masks are medical devices regulated by the FDA?

Mar 10, 2023 · N95 respirators, surgical masks, face masks, and barrier face coverings offer different levels of protection for the wearer from particles.

Sep 5, 2023 · This guidance provides a policy to expand the availability of face masks and barrier face coverings during the COVID-19 pandemic.

Nov 8, 2023 · Medical devices used to diagnose or treat COVID-19 include diagnostic tests, masks, gowns, gloves, sterilizers, and ventilators.

Mar 24, 2020 · The September 2021 version included barrier face coverings intended for a medical purpose but not intended to provide liquid barrier protection.

This site provides a listing of NIOSH-approved particulate filtering facepiece respirators. This type of air-purifying respirators protects by filtering ...

NIOSH Approved N95 · P100 · P95 Respirators · N99 Respirators

Face Masks, Barrier Face Coverings, Surgical Masks, and Respirators for COVID-19. Content current as of: 01/30/2024. Regulated Product(s). Medical Devices.

Mar 23, 2022 · Both BFE and PFE must meet the requirements of ≥95% for low-barrier face masks (level 1) and ≥98% for moderate- and high-barrier face masks ( ...