Key Assessment Indicators of KN95 and N95 Masks

KN95 masks are regulated by the Chinese government under regulation GB2626-2006 and are rated to filter 95% of particles. In April of 2020, in order to help expand the availability of general use face masks for the general public and particulate filtering facepiece respirators for healthcare professionals during the COVID-19 pandemic, the FDA issued guidance authorizing the use of KN95 masks as suitable NIOSH alternatives under certain emergency circumstances and FDA .
        
  
On May 7th of 2020, the FDA updated the April guidance and issued further guidance limiting the use of certain KN95 masks as suitable NIOSH alternatives in a healthcare setting .
   
 
The N95 mask is certified in accordance with Appendix K-Filtered Particulate Filters of NIOSH-42CFR Part 84, Standard Certification for Respiratory Protective Equipment. Appendix K divides the filters into self-priming filtered anti-particulate respirators and air-fed filtered anti-particulate respirators. Self-priming anti-particle filter elements are divided into N, R and P according to the filtration performance, N is suitable for filtering non-oily particles, R and P are suitable for filtering oily and non-oily particles, P filter elements use longer time limit than R, R filter elements use time is generally 1 working day, P can be recommended by the manufacturer according to demand.
 
N95 and KN95 masks both filter up to 95% of particles and create an air tight seal around the face. Under the current US regulatory framework mentioned above, as of April 8th 2020, the FDA has authorized the emergency use of KN95 masks and  FFP2 masks where there is a shortage of NIOSH approved N95 masks and FDA.

KN95 vs N95 In key assessment indicators: 

Test items\Mask Type KN95 N95
Filtration efficiency √ √
expiratory valve air tightness √ √
respiratory resistance √  
visual field √  
headband √ √
connections and connecting parts √  
lenses √  
leakage √  
dead space √  
air tightness √  
flammability √  
cleaning and disinfection √  
information provided by manufacturer √  
packaging √ √
 breathing resistance   √
inspiratory and expiratory valve requirements   √
instructions for use   √
parts and attributes requirements   √
marking   √