NIOSH Approval: What NIOSH Approval Means for N95 Masks

Now more than ever, the use of N95 masks or respirators has been spotlighted because of the COVID-19 pandemic. Whether you are looking to buy N95 masks for COVID-19 protection or a variety of other reasons, such as a need for respiratory protection due to chemicals and other dangerous inhalants, many factors go into the N95 purchasing decision.

For one thing, you may have heard the word "NIOSH approved" concerning N95 respirators, surgical respirators, and other particulate respirators a lot in the last year. Although they are surely important, not everyone knows what it means.

With that in mind, this article will explain what NIOSH approval implies and why NIOSH-approved masks are vital.

What is a NIOSH Certification?

The sign of NIOSH certification is perhaps the clearest and most crucial indicator to look for in an N95 respirator. The National Institute of Occupational Safety and Health (NIOSH) is a branch of the Centers for Disease Control and Prevention (CDC). Essentially, NIOSH is in charge of N95 mask approval and certification as a valid particulate respirator. Like other governing and regulatory bodies, NIOSH has criteria, procedures, and tests that masks must meet for products, product lines, manufacturers, and manufacturer quality control systems to be approved.

An N95 respirator, for example, must filter at least 95% of airborne particles, hence the name.

The process of obtaining NIOSH approval can take anywhere from four to eight months. Nonetheless, the comprehensive and demanding procedure assures that items such as N95 masks fulfill the quality, safety, and performance criteria necessary to be sold in their respective categories and sufficiently protect individuals.

What does NIOSH-Approved Mean?

As established, the NIOSH is a government agency and a branch of the Centers for Disease Control and Prevention responsible for conducting research and making recommendations to prevent workplace injuries and illnesses.

Following the onslaught of the pandemic, NIOSH has gotten informed by phone calls and emails from respirator users that certain respirator manufacturers may not fully comprehend what NIOSH approval entails. In some cases, manufacturers have claimed that because their company has one NIOSH approval, every respirator their facility makes is also NIOSH authorized, according to these respirator users.


To debunk such claims, keep in mind that NIOSH clearance only gets awarded to a specific and full respirator assembly after being assessed in the lab. This assembly found that the mask meets all of the requirements of Title 42, Code of Federal Regulations, Part 84, as well as the manufacturer's quality plan.

A NIOSH approval is only valid for the respirator that contains the components listed on the NIOSH approval label. The assignment of a NIOSH approval number to a respirator manufacturer does not imply that every respirator produced in that facility is also NIOSH approved. It also prohibits the manufacturer from altering the respirator's form, fit, function or from claiming NIOSH approval for features that are not approved and certified by NIOSH.

 Finally, any respirator producer who makes misleading statements like these might have all NIOSH approvals revoked.

What is the Importance of NIOSH-Approved Masks?

Because individuals needing appropriate protection rely greatly on the respirator's accurate performance rating, NIOSH approval is critical. A NIOSH-approved N95, for example, has a 95% confidence or higher efficiency rating, which means it prevents at least 95% of non-oil-based airborne particles. If you were using a non-NIOSH-approved respirator mask, you have no idea how efficiently it prevents airborne particulates or viruses.

If you are unsure if a respirator mask you bought is NIOSH certified, consult the CDC's Respirator Trusted-Source Information standards. Every NIOSH-approved respirator should include several visible marks and labeling on the respirator itself or the product's packaging. Be cautious of respirator masks that are completely devoid of NIOSH markings.

How Do You Know if Your Respirator is NIOSH-Approved?

Unfortunately, due to the rise in demand, many people have taken advantage of the COVID-19 situation to market non-NIOSH-approved masks as NIOSH-approved. While the TC number and private label holder (KOSTO) are valid, the misspelling of NIOSH on the front of the respirator identifies this unauthorized unit.

Following that, authorities have warned the public against the sale of counterfeit respirators. Counterfeit respirators are erroneously promoted and sold as NIOSH-approved yet cannot provide workers with adequate respiratory protection.


Aside from this warning, NIOSH has promised that as soon as it learns about counterfeit respirators or those on the market misrepresenting NIOSH clearance, it will post them as quickly as possible to alert users, customers, and producers.

With that, NIOSH gave out some guidelines to ensure approval. You can find an approval label on or within the packaging of NIOSH-approved respirators on the box itself or inside the user's instructions. On the FFR itself, there is also an abbreviated approval. To see if the respirator has been certified by NIOSH, look for the approval number on the NIOSH Certified Equipment List (CEL) or the NIOSH Trusted-Source page. Notably, NIOSH-approved FFRs will always have the following designations: N95, N99, N100, R95, R99, R100, P95, P99, P100.

Contrarily, there are signs that a respirator may be counterfeit:

  • The filtering facepiece respirator has no markings at all
  • On the filtering facepiece respirator or headband, there is no approval (TC) number
  • There are no NIOSH marks on the item
  • The acronym NIOSH gets misspelled
  • The presence of decorative fabric or other embellishments (e.g., sequins)
  • Claims of approval for children
  • Instead of headbands, the filtering facepiece respirator includes ear loops

The Merilogy Difference

Merilogy has been producing N95 masks in the United States to assist in the protection of the heroic men and women on the front lines who are keeping everyone safe and healthy during this pandemic. Notably, Merilogy's N95 particulate respirators get approved for use by the National Institute for Occupational Safety and Health (NIOSH).

Staying true to their mission to provide rapid access to premium-quality government regulated medical supply for the domestic market, Merilogy remains committed to helping out in the best way they know how — providing quality N95 respirator masks.


Merilogy proudly offers N95 respirators with the following features:

  • Proudly Made in the USA by Merilogy Inc. in California, Model # 501831.
  • NIOSH Approved N95 certified for at least 95 percent filtration efficiency against certain non-oil-based particles. [NIOSH Approval#: TC-84A-9294]
  • Dual-headband design and the adjustable nose clip enforce a secure seal for the majority of the user.
  • Folding design with center stitching that can create a breathable room between the mouth and the inner surface of the mask.
  • Durable latex-free material to ensure wearing comfort and safety and compatibility with a variety of protective eyewear and hearing protection.


As respirator use becomes the new norm, respiratory protection is receiving a lot of attention in the news, at workplaces, and from broad public conversation. With so much emphasis on respirators, individuals who use one must access the relevant information for whatever purpose or reason for use. Consider Merilogy's N95 Particulate Respirators, which get designed with your health in mind.