LMIC solutions: N95 equivalencies

Introduction / overview

N95 respirators and surgical masks are examples of personal protective equipment (PPE) that are used to protect the wearer from airborne particles and from fluid contaminating the face.

An N95 respirator is a respiratory protective device designed to achieve a very close facial fit and very efficient filtration of airborne particles. Note that the edges of the respirator are designed to form a seal around the nose and mouth. N95 respirators are commonly used in healthcare settings and are a subset of N95 Filtering Facepiece Respirators, often referred to as N95s.

Some N95 respirators are intended for use in a healthcare setting. Specifically, single-use, disposable respiratory protective devices are used by healthcare personnel during procedures to protect both the patient and healthcare worker from the transfer of microorganisms, bodily fluids, and particulate material. 

	Understanding the Difference
	Surgical Mask	N95 Respirator
Testing and Approval	Cleared by the U.S. Food and Drug Administration (FDA)	Evaluated, tested, and approved by NIOSH as per the requirements in 42 CFR Part 84
Intended Use and Purpose	Fluid resistant and provides the wearer protection against large droplets, splashes, or sprays of bodily or other hazardous fluids. Protects the patient from the wearer’s respiratory emissions	Reduces wearer’s exposure to particles including small particle aerosols and large droplets (only non-oil aerosols)
Face Seal Fit	Loose-fitting	Tight-fitting
Fit Testing Requirement	NO	YES
User Seal Check Requirement	NO	Yes. Required each time the respirator is donned (put on)
Filtration	Does NOT provide the wearer with a reliable level of protection from inhaling smaller airborne particles and is not considered respiratory protection	Filters out at least 95% of airborne particles including large and small particles
Leakage	Leakage occurs around the edge of the mask when user inhales	When properly fitted and donned, minimal leakage occurs around edges of the respirator when user inhales
Use Limitations	Disposable. Discard after each patient encounter.	Ideally should be discarded after each patient encounter and after aerosol generating procedures. It should also be discarded when it becomes damaged or deformed; no longer forms an effective seal to the face; becomes wet or visibly dirty; breathing becomes difficult; or if it becomes contaminated with blood, respiratory or nasal secretions, or other bodily fluids from patients.

3M comparison of KN95, FFP2, and N95 filtering facepiece respirators across the world.

Filtering facepiece respirators, sometimes called disposable respirators, are subject to various regulatory standards around the world. These standards specify certain required physical properties and performance characteristics in order for respirators to claim compliance with the particular standard.

During pandemic or emergency situations, health authorities often reference these standards when making respirator recommendations, stating, for example, that certain populations should use an “N95, FFP2, or similar” respirator.

This article is intended to help clarify some key similarities between such references, specifically to the following FFR performance standards:

• N95 (United States NIOSH-42CFR84)
• FFP2 (Europe EN 149-2001)
• KN95 (China GB2626-2006)
• P2 (Australia/New Zealand AS/NZA 1716:2012)
• Korea 1st Class (Korea KMOEL – 2017-64)
• DS2 (Japan JMHLW-Notification 214, 2018)

As shown in the following summary table, respirators certified as meeting these standards can be expected to function very similarly to one another, based on the performance requirements stated in the standards and confirmed during conformity testing.

Sources & links

• 3M | Comparison of FFP2, KN95, and N95 and other filtering facepiece respirator classes | Link
• FDA | N95 respirators, surgical masks, and face masks | Link
• Ontario Health | N95 equivalents as an alternative to N95 respirators in a health care setting | Link (PDF)