N95’s and NIOSH

Particulate respirators are designed to help reduce the wearer’s exposure to airborne particulate hazards. In the U.S., respirators are tested and certified by the U.S. National Institute of Occupational Safety and Health (NIOSH). NIOSH tests and certifies respirators based on their physical and performance characteristics, including filtration efficiency. For example, N95-rated filtering facepiece respirators have a filtration efficiency of at least 95% against non-oily particles when tested using the NIOSH criteria. The particles used to test the filtration are in a size range that is considered the most penetrating. Therefore, the test methods ensure that the filter media can filter particles with at least 95% efficiency.

FDA-cleared surgical masks

Surgical masks, in contrast, are designed to be worn by healthcare professionals during surgery and other medical tasks, to help prevent contamination of the surgical field and/or the patient by capturing liquid droplets that are expelled by the wearer. Surgical masks are cleared for use as medical devices by the U.S. Food and Drug Administration (FDA), or equivalent agencies outside the U.S. That clearance is based on data and proposed claims provided by the manufacturer to the FDA for review, in which the FDA evaluates and then “clears” for those products that meet their requirements. Because surgical masks are meant for use during surgeries, a key performance requirement is fluid resistance – the ability of masks to resist penetration by high-pressure streams of liquid, such as those that might result from a human artery being punctured during surgery.1

Surgical N95 Respirators

Surgical N95 respirators are both approved by NIOSH as an N95 respirator and also cleared by the FDA as a surgical mask. These products are frequently referred to as medical respirators, healthcare respirators, or surgical N95s.

Comparing standard N95’s and surgical N95’s

Putting this all together will help you differentiate between a standard NIOSH-approved N95 respirator and a surgical N95 respirator. While similar in appearance, the key difference is the fluid resistance and the resulting FDA clearance of surgical N95s. But when is that fluid resistance necessary?

Many tasks performed by healthcare workers – such as patient intake and non-emergency patient evaluation – pose little risk of generating high-pressure streams of liquid and are not conducted in a sterile field. For workers performing such tasks, a primary potential hazard to consider is airborne droplet containing viruses and bacteria, such as those generated by coughs and sneezes, which can be effectively filtered by a properly selected and worn N95 respirator.

Therefore, if a healthcare facility is prioritizing respirator use – due to limited supply during a health emergency – they may want to consider prioritizing use of surgical N95 respirators for those healthcare workers requiring respiratory protection while performing surgery or other tasks that may expose them to high pressure streams of bodily fluid or conducting work in a sterile field. The US Centers for Disease Control and Prevention (CDC), in their webpage Frequently Asked Questions about Personal Protective Equipment, says, “In times of shortage, only healthcare professionals who are working in a sterile field or who may be exposed to high velocity splashes, sprays, or splatters of blood or body fluids should wear these [surgical N95] respirators, such as in operative or procedural settings.”2 For other workers who will not be performing such surgical procedures or do not need to maintain a sterile field, a standard non-surgical N95 (or equivalent) respirator can be worn to help reduce those workers’ exposure to patient-generated airborne viruses and bacteria.