Surgical N95 respirators approved under the MOU do not require FDA’s 510(k) clearance. These NIOSH-approved surgical N95 respirators are only on the Certified Equipment List (CEL) . A respirator labeled as a KN95 respirator is expected to conform to China’s GB2626 standard.

N95 respirators must form a seal to the face to work properly. This is especially important for people at increased risk for severe disease. Wearing an N95 respirator can make it harder to breathe. If you have heart or lung problems, talk to your doctor before using an N95 respirator. Some N95 respirators may contain latex in the straps.

NIOSH filter series and filter efficiency level, e.g., N95, N99, N100, R95, P95, P99, P100. Model number or part number: The approval holder’s respirator model number or part number, represented by a series of numbers or alphanumeric markings, e.g., 8577 or 8577A.

• NIOSH filter series and filter efficiency level, which will be N95 (for other FFR types, it could be N99, N100, R95, R99, R100, P95, P99, or P100) • NIOSH Testing and Certification approval number, e.g., TC-84A-XXXX • NIOSH in capital block letters • Lot number may be on the N95 abbreviated label or the product packaging

This list is reviewed and updated weekly. This table of Surgical N95’s is provided as a courtesy. If you have a product that you believe is FDA cleared that does not appear on this table, you should verify the FDA clearance by contacting the FDA at 1-800-638-2041.

How to Properly Put on and Take off a Disposable Respirator WASH YOUR HANDS THOROUGHLY BEFORE PUTTING ON AND TAKING OFF THE RESPIRATOR.

Mar 15, 2023 · How to tell if your N95 Respirator is NIOSH Approved [PDF – 561 KB] Suggested Citation. NIOSH [2021]. How to tell if your N95 respirator is NIOSH approved. By Cichowicz J, Andrews A, Fries M. Pittsburgh, PA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and ...

The N95 respirator is the most common of the seven types of particulate filtering facepiece respirators. This product filters at least 95% of airborne particles but is not resistant to oil-based particles. This web page provides a table of NIOSH-approved N95 respirators listed by manufacturer from A-Z.

Sep 24, 2021 · Surgical N95 respirators approved under the MOU do not require FDA’s 510(k) clearance. These NIOSH-approved surgical N95 respirators are only on the Certified Equipment List (CEL) . A respirator labeled as a KN95 respirator is expected to conform to …

The N95 respirator is the most common of the seven types of particulate filtering facepiece respirators. This product filters at least 95% of airborne particles but is not resistant to oil-based particles. This web page provides a table of NIOSH-approved N95 respirators listed by manufacturer from A-Z.