The KN95 medical masks (particulate respirators) are regulated according to the guidelines specified by the Chinese Government under the GB2626-2006 standards. As a response to the emergency COVID-19 pandemic situation, FDA has authorized the KN95 particulate respirators to be used in medical emergencies where there is a shortage of NIOSH approved N95 respirators (April 2020).
Source:https://www.fda.gov/medical-devices/personal-protective-equipment-infection-control/faqs-shortages-surgical-masks-and-gowns
https://www.fda.gov/media/136449/download.
However, FDA issued another guideline on May 7th, 2020 to limit the usage of some KN95 mask models as an alternative to the NIOSH approved N95 respirators.
Source:https://www.fda.gov/medical-devices/personal-protective-equipment-infection-control/faqs-shortages-surgical-masks-and-gowns
https://www.fda.gov/media/136449/download
KN95 medical masks (particulate respirators) are cup-design, medical grade, and nonwoven masks. These masks are made of 3 layers of nonwoven, needle filter cotton fabric and these thick layers help provide effective respiratory protection against dust and certain biological particles. It also incorporates an adjustable nose bridge and elastic ear loops to provide a comfortable fit and function efficiently.
KN95 masks are intended to isolate at least 95% of 0.3 microns particles. KN95 medical masks offer the same level of filtering efficiency (95%) against certain airborne particles, as compared to N95 respirators. It also provides a secure seal around the nose and face. KN95 masks usually use the ear-loop method of wearing the masks. The construction of KN95 respirator makes it easier to put on and take off the respirator.
