N95 Mask Respirators & KN95 Masks

In addition to CE, other countries such as China have also developed their own national standards of approval for respiratory protective equipment which has become globally recognized. In China, all disposable respirators must comply with KN95 (GB2626-2019) standards. The KN95 regulatory standard refers to a design that ensures filtration efficiency, tight seal with the face as well as minimum leakage.

Comparison of NIOSH N95 and KN95 Respirators

Filtering facepiece respirators (FFR) are subject to various regulatory standards around the world (see table below) and provide a much higher level of protection with face form fitting and greater pressure drop. To claim compliance with a particular standard as listed below, these respirators must meet or exceed required physical properties and performance characteristics, which can vary according to the regulatory bodies of different countries.

Certification/Class (Standard)	N95 (NIOSH-42 CFR84)		KN95 (GB2626- 2019)
Filter performance (must be ≥ X% efficient)	≥ 95%		≥ 95%
Test agent			NaCl
Flow rate	85 L/min		85 L/min
Total inward leakage (TIL) – tested on human subjects each performing exercises*	N/A		≤ 8% leakage (arithmetic mean)
Inhalation resistance – max pressure drop	≤ 343 Pa
Flow rate	85 L/min
Exhalation resistance - max pressure drop	≤ 245 Pa		≤ 250 Pa
Flow rate	85 L/min		85 L/min
Exhalation valve leakage requirement	Leak rate ≤ 30 mL/min		Depressurization to 0 Pa ≥ 20 sec
Force applied	-245 Pa		-1180 Pa
CO2 clearance requirement	N/A		≤ 1%

*Please note: Respirators may be designed to fit people with facial features common in a specific country or region. For example, KN95 respirators may be designed specifically to fit people with facial features common in China and other countries in Asia. As a result, some individuals with different facial features may not be able to achieve a satisfactory fit. This should be considered when selecting and using a respirator approved to other countries and region’s standards.