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NIOSH Listed N95 Masks: Explaining the Approval Process

Oct 20, 2022

At Pacific Medical Products, it’s vital that our N95 masks are FDA cleared, CDC listed, and NIOSH approved. While we may be aware that these seals demonstrate the verification of an effective face-mask, what exactly do all of these acronyms necessarily mean? Let’s focus on one of these approval authentications, being NIOSH, to explain what this agency does and how their mask testing process works.

NIOSH: Agency History and Responsibilities

NIOSH, which stands for the National Institute of Occupational Safety and Health, conducts research and makes recommendations to prevent work-related injuries and illness. As the U.S. agency was developed following the Occupational Safety and Health Act of 1970, NIOSH quickly became established with a goal to empower employers and workers to create safe and healthy work environments. NIOSH is a part of the U.S. Center for Disease Control and Prevention (CDC) and employs more than 1,300 people in a variety of fields including epidemiology, medicine, nursing, industrial hygiene, safety, psychology, statistics, engineering, economics, and chemistry.

The NIOSH website lists seven strategic goals when it comes to representing the U.S. workforce, being:

  1. Reduce occupational cancer, Cardiovascular disease, adverse reproductive outcomes, and other chronic diseases.
  2. Reduce occupational hearing loss.
  3. Reduce occupational immune, infectious, and dermal disease.
  4. Reduce occupational musculoskeletal disorders.
  5. Reduce occupational respiratory disease.
  6. Improve workplace safety to reduce traumatic injuries.
  7. Promote safe and healthy work design and well-being.

While goals 3, 5, and 7 most directly refer to respiratory health, NIOSH protects employee health and safety across all U.S. work environments.

NIOSH Listed Masks

When establishing the protective quality of a face-mask, NIOSH utilizes three letter designations to differentiate mask utilization. The letter “N” indicates that the respirator is not resistant to oil, “R” indicates that the mask is somewhat resistant to oil, and “P” indicates that the mask is strongly resistant to oil. All approved respirator designations are listed below:

  • N95: Filters at least 95% of airborne particles and not resistant to oil.
  • Surgical N95: An N95 respirator that has also been cleared by the FDA as a surgical mask.
  • N99: Filters at least 99% of airborne particles and not resistant to oil.
  • N100: Filters at least 99.97% of airborne particles and not resistant to oil.
  • R95: Filters at least 95% of airborne particles and somewhat resistant to oil.
  • P95: Filters at least 95% of airborne particles and strongly resistant to oil.
  • P99: Filters at least 99% of airborne particles and strongly resistant to oil.
  • P100: Filters at least 99.97% of airborne particles and strongly resistant to oil.

In addition to respirator designation, there’s also five essential mask labels that help display the usability and authentication of your face-mask. These essential labels are:

  1. Approval Holder: This is the mask manufacturers name of business.
  2. NIOSH: NIOSH logo in block letters.
  3. Approval Number: This is the NIOSH testing and certification approval number, beginning with “TC-“.
  4. Filter Efficiency Designation: This is the NIOSH filter designations, e.g., N95, N100, P95, etc.
  5. Model/Lot Number: The approval holder’s respirator model number.

Now that you’re aware of this information, make sure to first verify your mask labels before wearing it in your work environment.

Pacific Medical Products

Listed below are some of the NIOSH Approved medical masks available for purchase on our website:

We understand there’s a lot of concern about fake masks. We purchase all of our masks from Medline or McKesson (two of the world’s largest 3M distributors) who, by contract, can only buy them direct from the manufacturer. Every mask is 100% authentic with lot numbers that can be tracked back to the manufacturer. Quality and trust are of utmost importance to us at Pacific Medical Products.