Today we introduce our newest product, the KN95 Respirator Mask to the Chinese standard GB2626-2006. Introduced in the US market in response to the Corona virus pandemic and approved for use under the CDC’s EAU, the KN95 is currently being used for protection against Covid-19.
Regulated by the Chinese government (CE), a KN95 respirator mask is a type of Filtering Facepiece Respirator (FFR). Similar in function to the USA N95s, KN95s have a minimum of 95% filtration and a maximum 8% leakage to the inside and are made to the GB2626-2006 standard.
2. Who uses KN95 respirator masks?
Mainly used in construction, agriculture, and by healthcare professionals against airborne particles, infectious agents and viruses, KN95s prevent the wearer from inhaling aerosols (dust, smoke, mist) as well as vapors or gases (disinfectants, anesthetic gases, droplets) that are health hazards. KN95s are currently used for protection against the coronavirus.
Interesting fact: Prior to Covid-19, there were ample USA N95s available in the marketplace and KN95s and other country’s FFPs were not widely available in the US.
3. What is the difference between the N95, the KN95 and other FFPs?
N95s, KN95s & other FFPs are all respirator masks that are subject to various regulatory standards around the world. Respirators certified to these standards are expected to have similar performance. There are slight differences in their specifications, like a variation in the maximum pressure the masks must be able to withstand as a person inhales and exhales. Here are the global standards by country:
- N95 (United States NIOSH-42CFR84)
- FFP2 (Europe EN 149-2001)
- KN95 (China GB2626-2006)
- P2 (Australia/New Zealand AS/NZA 1716:2012)
- Korea 1st class (Korea KMOEL – 2017-64)
- DS (Japan JMHLW-Notification 214, 2018)
On March 24, 2020, the FDA issued an Emergency Use Authorization (EUA) for importing non-NIOSH approved N95 equivalent respirators from Australia, Brazil, Europe, Japan, Korea, and Mexico who have similar standards to NIOSH. On April 3, 2020, in response to continued respirator shortages, the FDA approved the EAU for Chinese KN95s. KN95s are almost identical in performance to N95 masks. The CDC lists KN95 masks as a suitable alternative when N95s are not available. The FDA says KN95 masks are eligible for authorization if they meet certain criteria, including documentation that they are authentic.
5. Are KN95 and other respirator masks reusable?
Although KN95 respirator masks are meant for single use, the CDC offers guidance on reuse and cleaning of FFPs here: Recommended Guidance for Extended Use and Limited Reuse of N95 Filtering Facepiece Respirators in Healthcare – cdc.gov
6. How do I know my mask is authentic & not counterfit?
Make sure to purchase any Personal Protective Equipment from a reliable supplier who has experience supplying certified and compliant parts. A reliable supplier will be able to provide you with authentic CE & FDA certifications and should be able to show you how to check that the manufacturer is registered with the FDA. Upon request, a supplier should provide you with a certificate of conformance stating the product has been checked and conforms to the KN95 GB2626-206 standard.
7. What is the price range of the KN95 respirator mask?
KN95s have a wide price range based on quantity, availability and level of certification available. Today, demand far outweighs current supply of FFPs. Beyond the economics of supply & demand, the factors that go into the price of a KN95 include material costs, labor, transporation, duties & tariffs. China is the main manufacturer of Personal Protective Equipment, and since the Covid-19 outbreak, flights from China to the US are limited, inflating the freight costs. In addition, the special nonwoven filtering fabric used in KN95s has also become an in demand commodity. All these factors have led to increased costs. Over time, as supply meets demands, and flights fly more frequently, we expect prices to decrease.
Stay tuned for our next blog, where we discuss our expanded PPE offering, including gloves, hand sanitizer, 3 Ply masks and other PPE.
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