KN95 Respirator Masks
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 general use 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
Each order contains 1 Sealed Kn95 Mask.
Filtering respirator face masks are subject to various regulatory standards and compliance guidelines from around the world. These guidelines and standards specify the required physical properties, performance characteristics and functionality necessary for achieving a particular standard within a particular country. During emergency situations such as epidemics and pandemics, health authorities may authorize the use of certain foreign standards of face piece respirators such as N95, KN95, or FFP2 equivalent. This article will seek to identify and describe some of the most commonly available respirator standards around the world as well as provide a summary of the current regulatory framework under the FDA in the United States with respect to the 2019 novel coronavirus and associated COVID-19 pandemic. This article was last updated on May 7th, 2020.
The most common face-piece respirator standards from across the globe are as follows:
- N95/N99 – United States NIOSH
- FFP2/FFP3 – Europe CE EN 149:2001+A1:2009
- KN95 – China GB2626-2006
- Special 1st – Korea KMOEL – 2017-64
- P95 – Mexico NOM-116-2009
- P2/P3 – Australia AS/NZS 1716:2012
- DS/DL2/DL3 – Japan JMHLW-200