N95, KN95 and the EUA route
Why a non-NIOSH respirator was allowed into US use during the pandemic, and what that permission actually rested on.
The two standards
N95 is the NIOSH designation under US regulation. KN95 is the equivalent under China's GB 2626-2006. Both filter non-oil particles above 0.3 microns at a minimum 95% efficiency; the published differences are mostly in the maximum pressure drop permitted during inhalation and exhalation.
What an EUA is
During a declared public health emergency, the FDA can use Emergency Use Authorization to permit unapproved products, or unapproved uses of approved products, where there is no adequate approved alternative. The old site quoted the FDA directly on this and linked the source.
The CDC assessment
The CDC runs an International Respirator Assessment that takes requests from agencies, employers and healthcare systems and evaluates imported respirators. Its conclusions carry weight and have been used to remove suppliers who failed to hold their quality commitment.
What this means now
Emergency authorisations are time-limited and market-specific. Anything you read about KN95 acceptance during the pandemic should be re-checked against the current position in your market before you buy on that basis.
Where this applies in the catalogue
The guidance above is general. Applied here, it lands hardest on the disposable masks family.
