FDA Listed PPE
CE approved and FDA listed PPE, and where the KN95 respirator sits alongside the NIOSH N95.
KN95 respirators are part of the front-line response to SARS-CoV-2. The FDA issued an Emergency Use Authorization for the KN95 respirator; regulated under China's GB 2626-2006 standard, it is close to identical in performance to the NIOSH-approved N95, filtering non-oil particles larger than 0.3 microns at a minimum 95% filtration efficiency.
The published differences are largely in the maximum pressure drop the mask withstands while the wearer inhales and exhales. The CDC has listed the KN95 respirator as a suitable alternative when N95s are not available.
Sources: CDC, "Strategies for Optimizing the Supply of N95 Respirators"; Kenneth Chang, "F.D.A. to Allow Use of KN95 Masks Approved by China", The New York Times, 3 April 2020.
Reproduced from TIANCHIMED’s own news post of 1 May 2020, with its original citations kept.