ABCs of N95s: Guide to N95 Quality Assurance

It turns out The Jackson 5 were right: ABC really is as easy as 123. What the famed group probably didn’t realize is their catchy chorus would provide a great framework to think about the value of N95 respirators.

In a healthcare system still adjusting to the progression of a global pandemic approaching its third year, understanding the considerations and requirements of facial protection in the healthcare setting has been a critical-yet-moving target.

If you or your staff wear an N95 as part of your day-to-day job, here’s how to ensure you have the protection you need. It’s as easy as remembering the ABCs and 123s.

A is for Accessible

Simply put, if the N95 isn’t on your face, it’s not helping you. The pandemic placed unprecedented pressure on the global supply chain, making it even more important for hospitals to pay attention to their personal protective equipment (PPE) suppliers. Having an N95 supplier that has a reliable, accessible Americas-based supply chain ensures the product is there when you need it, in the amount you need.

All HALYARD* FLUIDSHIELD* N95 respirators are made in the Americas. They do not rely on manufacturing in Asia which decreases the chances of supply chain disruptions.

FLUIDSHIELD* Level 1 Anti-Fog Surgical Mask

FLUIDSHIELD* Level 1 Anti-Fog Surgical Mask

B is for Breathable

Most people immediately think of the filtration level as the most important part of an N95’s protection. But the breathability and comfort of the respirator are just as important when maximizing protection. The more comfortable a respirator is, the less likely the wearer is to adjust it, which means there are fewer fit and contamination issues. This becomes even more critical for N95s, which require fit testing to meet industry standards.1

The design of a respirator has a lot to do with how breathable it is. HALYARD* FLUIDSHIELD* N95 respirators have a breathing chamber that’s twice as large as the leading competitive cone style surgical N95. And they meet and exceed NIOSH standards for breathability. They also:

  • Come in two sizes to ensure a better fit
  • Have malleable, adjustable nose wires
  • Contain strong elastic straps that are securely bonded, not stapled, to the respirator

C is for Certified

HALYARD* FLUIDSHIELD* N95 respirators are NIOSH approved and cleared by the FDA as medical devices for use in a healthcare setting.

Not all N95 respirators are cleared for use by healthcare workers. All N95 respirators do have to be certified by NIOSH to confirm that their performance meets federal regulations. However, respirators for medical use must also be cleared by the FDA as medical devices. They could alternatively be certified as surgical respirators by NIOSH.2 In either case the respirators must meet additional requirements for splash resistance, flammability and biocompatibility.

During the pandemic, the FDA issued a temporary Emergency Use Authorization that allowed the use of respirators that had not been cleared by the FDA as medical devices to be used by healthcare workers. That EUA not only included industrial NIOSH approved respirators, but also included respirators that complied with European and Asian regulations, such as FFP2s and KN95s. In June of 2021 the FDA announced the revocation of emergency use authorizations (EUA) for non-NIOSH-approved disposable respirators and decontamination systems because access to NIOSH approved respirators improved.

In addition to regulations enforced by the above-referenced agencies, ASTM International develops consensus standards, such as the ASTM F2100 Standard Specification for Performance of Materials Used in Medical Face Masks and the ASTM F1862 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood. The specifications for medical masks under ASTM F2100 covers criteria for filtration, breathability, fluid resistance and flammability.

HALYARD* FLUIDSHIELD* N95 respirators provide either Level 2 (moderate) or Level 3 (high) levels of resistance to penetration by fluid splashes, depending on the model.

ASTM F2100 Chart


  1. Centers for Disease Control and Prevention. Types of Masks and Respirators. Retrieved January 18, 2022 from
  2. S. Food & Drug Administration. N95 respirators, Surgical Masks, Face Masks, and Barrier Face Coverings. Retrieved January 18, 2022 from


N95 Masks