Comparing the KN95 Mask vs the N95 Mask – Plus Current FDA Guidelines Surrounding the COVID-19 Pandemic

Filtering facepiece respirators (FFR), which are sometimes called disposable respirators, are subject to various regulatory standards around the world. These standards specify certain required physical properties and performance characteristics in order for respirators to claim compliance with the particular standard. During pandemic or emergency situations, health authorities often reference these standards when making respirator recommendations, stating, for example, that certain populations should use an “N95, FFP2, or equivalent” respirator.

Most regulatory standards for FFRs have similar, but not identical, test methods and respirator classes. The most commonly used respirator class descriptor is filtration efficiency. This is the ability of a respirator to filter a specific particle in a controlled laboratory test. Because of similarities in standard requirements, the following respirator classes, from various countries and regions, all have approximately 94-95% filtration efficiency, are designed to form a seal with the face, and may be considered to be functionally similar for most uses against non-oil airborne particles:

  • Australia/New Zealand - P2
  • Brazil - P2
  • China - KN95, KP95
  • Europe - FFP2
  • Japan - DS2, DL2
  • India - BIS P2
  • Korea - 1st class
  • US NIOSH - N95, R95, P95

Comparing the N95 and KN95 filtering facepiece respirators (FFR), both filter up to 95% of particles and create an air tight seal around the face.

Under the current US regulatory framework, the FDA has authorized the emergency use of KN95 masks where there is a shortage of NIOSH approved N95 masks (Source: FDA https://www.fda.gov/media/136664/download).

The most commonly available and well-known respirators in the U.S. are the N95 PPE respirators; they filter up to 95% of particles and create an air tight seal around the face. These type of respirator masks are not specifically regulated by the FDA, they are regulated by the CDC and NIOSH. The FDA may regulate an N95 mask if the manufacturer chooses to market the mask for a medical purpose, and in such case it would need an FDA clearance. On March 2, 2020, in response to the COVID-19 pandemic, the FDA released guidance that certain NIOSH approved respirators not currently regulated by the FDA are cleared to be used in a healthcare setting by health care personnel during the emergency coronavirus outbreak (Source FDA https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-and-cdc-take-action-increase-access-respirators-including-n95s).

The 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 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 (Source:FDA https://www.fda.gov/medical-devices/personal-protective-equipment-infection-control/faqs-shortages-surgical-masks-and-gowns and FDA https://www.fda.gov/media/136449/download).