KN95 masks authorized under the FDA Appendix A are tested and monitored by the CDC in collaboration with NIOSH.
The DRMFYAN KN95 masks for sale are manufactured by Guangdong Zhizhen Biological Medicine Co Ltd. and are Appendix A authorized by the FDA under the Umbrella EUA for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs) Manufactured in China. These devices are evaluated using methods similar to those used by NIOSH and are still expected to provide adequate protection for healthcare personnel.
On April 3, 2020, the FDA issued an umbrella EUA for certain filtering face-piece respirators (FFRs) that are manufactured in China and are not approved by the National Institutes of Occupational Safety and Health (NIOSH).
You can view the FDA web site with the update EUA approved list of manufacturers at the link below:
With a soft and comfortable fit the DR MFYAN KN95 Mask protects against airborne bacteria and germs to help reduce the spread of viral infections and disease.
- For Healthcare, Business and Personal Use
- FDA Appendix A – EUA List Approved – CDC Tested
- CE Registered to Performance Standard GB2626-2006.
- Antibacterial Layer
- Pm 2.5 Standard
- Non-Woven Filtration Layer
- Dust Particle Protection
- Soft And Comfortable
- KN95 Rating
These multipurpose masks are perfect for business, personal and healthcare use to protect and prevent transmission of airborne virus particles. Each KN95 mask comes in an individually sealed package with it’s own certificate of authenticity including the manufacturing details and rating info. The outer box contains 50 individually sealed masks and includes a QR coded sticker seal for verification of authenticity,
DR MFYAN KN95 Mask Performance Rating
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.
FFR performance standards:
• N95 (United States NIOSH-42CFR84)
• KN95 (China GB2626-2006)
• FFP2 (Europe EN 149-2001)
• P2 (Australia/New Zealand AS/NZA 1716:2012)
• Korea 1st class (Korea KMOEL – 2017-64)
• DS (Japan JMHLW-Notification 214, 2018)
Respirators certified as meeting these standards can be expected to function very similarly to one another, based on the performance requirements stated in the standards and confirmed during conformity testing.