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An N95 respirator is a disposable filtering facepiece respirator or reusable elastomeric respirator filter that meets the U.S. National Institute for Occupational Safety and Health (NIOSH) N95 standard of air filtration, filtering at least 95% of airborne particles that have a mass median aerodynamic diameter of 0.3 micrometers under 42 CFR 84, effective July 10, 1995.
During the COVID-19 pandemic, the mask and respirator market rapidly grew, along with counterfeit respirators. [1] NIOSH, on behalf of the Department of Health and Human Services, filed a trademark application on June 17, 2020, for various 42 CFR 84 trademarks, including the N95, allowing NIOSH to enforce rules on counterfeit masks outside of rules defined in 42 CFR 84.
According to Dr. Kohl, N95 is the certification standard used in the United States to describe a tight-fitting respirator that filters out at least 95 percent of particles (down to 0.3 microns ...
Limited research suggests that elastomeric respirators may have better fitting characteristics than disposable filtering-facepiece respirators, fitting a broader variety of faces, and thus being more likely to seal well when the user has not done a formal fit test. Available evidence also suggests that as a class, elastomeric respirators may ...
These may also be labeled "Surgical N95", "medical respirators", or "healthcare respirators". [52] The difference lies in the extra fluid-resistant layer outside, typically colored blue. [ 53 ] In addition to 42 CFR 84, surgical N95s are regulated under FDA regulation 21 CFR 878.4040.
The OSHA has a similar document. The following respirator standards are considered similar to N95 in the US: [54] [55] Japanese DS2/RS2 (JMHLW-Notification 214, 2018): EU-like grades with two-letter prefix – first letter D/R stands for disposable or replaceable; second letter S/L stands for dry (NaCl) or oily particles. [7]
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