NIOSH and EUA Approvals

When it comes to purchasing PPE for your organization, it can get confusing to filter out the fraudulent and non-effective products. Due to COVID-19, many non-traditional PPE manufacturers have started to produce PPE to help combat and protect against the virus, but unfortunately, there has been an increase in fake products. As organizations continue to protect frontline and essential workers, staff, students and many others, it is critical that the PPE products received are top quality, approved and effective. See below for an overview of NIOSH certified vs. Non-NIOSH certified and to learn more about EUA approval during these times.

NIOSH approval comes from the National Institute for Occupational Safety and Health and has the highest efficacy rate of protection against airborne particles with 95 percent being the minimum level of filtration approved. One quick and easy way to check if PPE products, filtering face piece respirators in particular, are NIOSH approved is to check the designation number. The following designations are approved: N95, N99, N100, R95, R99, R100, P95, P99 and P100. N95 masks are regulated by the FDA as well under the regulatory collaboration of FDA and NIOSH which makes purchasing NIOSH approved masks for healthcare and essential workers one of the top ways to protect against COVID-19.

Non-NIOSH approved N95s will still filter out airborne particles, but are not at the same filtration percentage as NIOSH approved. If you are expecting NIOSH approved filtering face piece respirators, here are a few signs that a respirator may be counterfeit provided by the CDC:

  • No markings at all on the filtering face piece respirator
  • No approval (TC) number on filtering face piece respirator or headband
  • No NIOSH markings
  • Presence of decorative fabric or other decorative add-ons (e.g., sequins)
  • Claims for the of approval for children (NIOSH does not approve any type of respiratory protection for children)
  • Filtering face piece respirator has ear loops instead of headbands


Another frequently used approval during COVID-19 has been the Emergency Use Authorizations (EUAs). The EUA process is different from FDA approval or clearance. Under an EUA, in an emergency, the FDA makes a product available to the public based on the best available evidence, without waiting for all the evidence that would be needed for FDA approval or clearance. For an EUA to be cleared, there must be no available alternative for preventing the virus which is why there have been many EUAs presented during COVID-19 due to the PPE shortages.

The CDC has created a useful resource to help understand the dIfferent mask types and what they should be used for as well as the various certifications and requirements.

CDC. (2020, April 09). Approved particulate filtering facepiece respirators. Retrieved February 24, 2021, from

Center for Devices and Radiological Health. (2018, February 12). Personal protective Equipment (PPE) and other government agencies. Retrieved 2020, from

Commissioner, O. (2017, January). Emergency use authorization of medical products. Retrieved from

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