"N95" redirects here. For other uses, see N95 (disambiguation).
Further information: NIOSH air filtration rating
An N95 respirator[1] is a particulate-filtering facepiece respirator or elastomeric filter that meets the U.S. National Institute for Occupational Safety and Health (NIOSH) N95 classification of air filtration, meaning that it filters at least 95% of airborne particles that have a mass median aerodynamic diameter of 0.3 micrometers[2] under 42 CFR Part 84. This standard does not require that the respirator be resistant to oil; two other standards, R95 and P95, add that requirement. The N95 type is the most common particulate-filtering facepiece respirator.[3] It is an example of a mechanical filter respirator, which provides protection against particulates but not against gases or vapors.[4] An authentic N95 respirator is marked with the text "NIOSH" or the NIOSH logo, the filter class ("N95"), and, for filtering facepiece respirators (respirators with non-replaceable filters), a "TC" approval number of the form XXX-XXXX, the approval number. All N95 respirators, regardless of type, must be listed on the NIOSH Certified Equipment List (CEL)[5] or the NIOSH Trusted-Source page,[6] and it must have headbands instead of ear loops.[7]
Examples of N95 Respirators
A 3M 8210 filtering facepiece respirator
Surgical N95 respirators for use in health care are both approved by NIOSH (as a respirator) and cleared by FDA (as a fluid resistant surgical mask)
An elastomeric respirator with N95 filters installed. Note the lack of a TC number; TC numbers are absent on elastomeric respirators.
All of these respirators have been approved by NIOSH under 42 CFR Part 84,[8] and have been listed in the CEL.
N95 respirators are considered similar to other respirators regulated under non-U.S. jurisdictions, but slightly different criteria are used to certify their performance, such as the filter efficiency, test agent and flow rate, and permissible pressure drop. For example, FFP2 respirators of the European Union are required to meet at least 94% filtration, and KN95 respirators of China are expected to meet at least 95% filtration.[9] However, NIOSH found that some products labeled "KN95" failed to meet these standards, some of them filtering out as little as one percent.[10] Both the U.S. Food and Drug Administration and Health Canada require such KN95 products failing to meet the filtration standards to be re-labeled as "face masks" instead of "respirators",[11][12] when being sold in the U.S. and Canada.
The N95 respirator is commonly made of a fine mesh of synthetic polymer fibers, specifically a nonwoven polypropylene fabric.[13] It is produced by melt blowing and forms the inner filtration layer that filters out hazardous particles.[14]
^"Personal Protective Equipment: Questions and Answers". Centers for Disease Control and Prevention. February 11, 2020. Retrieved October 25, 2020.
^"42 CFR Part 84 Respiratory Protective Devices". The National Personal Protective Technology Laboratory. National Institute for Occupational Safety and Health. March 4, 1997. Retrieved June 8, 2023 – via U.S. Centers for Disease Control and Prevention.
^"NIOSH-Approved N95 Particulate Filtering Facepiece Respirators - A Suppliers List". U.S. National Institute for Occupational Safety and Health. March 19, 2020. Retrieved March 27, 2020.
^"Respirator Trusted-Source: Selection FAQs". U.S. National Institute for Occupational Safety and Health. March 12, 2020. Retrieved March 28, 2020.
^"Certified Equipment List | NPPTL | NIOSH | CDC". www.cdc.gov. June 4, 2020.
^"Respirator Trusted-Source Information | NPPTL | NIOSH | CDC". www.cdc.gov. August 3, 2020.
^"Counterfeit Respirators / Misrepresentation of NIOSH-Approval". NIOSH, Centers of Disease Control and Prevention. Retrieved October 27, 2020.
^Cite error: The named reference register was invoked but never defined (see the help page).
^"Comparison of FFP2, KN95, and N95 and Other Filtering Facepiece Respirator Classes" (PDF). 3M Technical Data Bulletin. January 1, 2020. Retrieved March 28, 2020.
^"Health Canada issues recall of some KN95 masks made in China". Canadian Broadcasting Corporation. Retrieved October 25, 2020.
^"Certain Filtering Facepiece Respirators from China May Not Provide Adequate Respiratory Protection - Letter to Health Care Providers". U.S. Food and Drug Administration. Retrieved October 25, 2020.
^"Important safety information for certain respirator masks". Health Canada. Retrieved October 25, 2020.
^Cite error: The named reference VOADeliver was invoked but never defined (see the help page).
^Feng, Emily (March 16, 2020). "COVID-19 Has Caused A Shortage Of Face Masks. But They're Surprisingly Hard To Make". Goats and Soda. NPR.
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