KN95 Guidance
KN95 is the equivalent international standard for N95. These respirators were never used by the US, and hence never passed the NIOSH (The National Institute for Occupational Safety and Health) tests. In response to the respirator shortage surrounding COVID-19 the FDA in an EUA allowed the import of KN95 masks, when meeting various criteria (described in the link below). This resulted in a large number of KN95’s being allowed into the US. Unfortunately, many of these previously allowed KN95 respirators proved to be unreliable and unsafe. The FDA therefore revised its guidance removing many KN95s from the list of approved Non-NIOSH masks for import. There has been retesting of many models and a gradual expansion of approved Non-Niosh respirators. In fact, there currently is an oversupply of foreign KN95 masks on the ground in the US (often selling at below cost). We recommend extreme care be used in selecting a foreign KN95, particularly for medical use. We also recommend sampling any model prior to order since there are marked differences in size and fit.
Updated
FDA Guidance on Non-Niosh Respirators
FDA Approved Non-Niosh Respirators (updated June 19th)
Useful NIOSH-Style test results for many KN95 models (updated June 19th)
Some background on the (currently) authorized Chinese KN95 manufacturers
