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What is a NIOSH N95 Respirator?
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The National Institute for Occupational Safety and Health (NIOSH) is the U.S. Government agency responsible for the certification and approval of respiratory protective devices for occupational use. The authority is granted to NIOSH in accordance with conditions and standards established in Title 42 of the Code of Federal Regulations (CFR), Part 84. It also addresses quality assurance requirements for the manufacturing of respiratory protective equipment. The approach to approval is that anybody can manufacture and sell any type of respiratory protective device, but only those that meet or exceed all of the requirements established in the 42 CFR Part 84 standards are acknowledged by NIOSH, and only those that have been NIOSH certified may be marketed as a NIOSH-approved respirator.


An N95 respirator is a sealing respirator that has been certified by NIOSH for occupational use.  A Surgical N95 respirator is a NIOSH-approved N95 respirator that has also been cleared by the Food and Drug Administration (FDA) as a surgical mask (Surgical N95s are noted in bold font on the table of NIOSH-approved N95 respirators). 


Special Note: NIOSH N95s are approved for medical use under the FDA’s emergency use authorization from March 2 and updated March 28th. They are considered a medical device for the duration of the EUA. FDA EUA Link


You can tell if an N95 respirator is legitimate by reviewing the markings on the front of the mask and then comparing them against the NIOSH listings on the website.


Each mask should list the manufacturer, the model number, the NIOSH Approval number, and the word NIOSH, or the NIOSH logo.

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