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Have the FDA Banned All KN95s?
Are you interested in buying or using the KN95 mask? Is there so much negative news out there about it deterring you from going on? Are kn95 masks fake?
It is confusing. It is scary. Is it safe?
Our team at bestcpapcleaner.com continues to get emails, calls, and texts about the KN95 Mask, and the goal of this post is to address three key questions or issues that come up.
Is the KN95 banned? Is it Counterfeit?
Here is what happened. When the COVID-19 pandemic emerged, there was a huge shortage of masks, specifically the N95 category. Governments and health authorities like the FDA lifted certain requirements to allow for respirators and face masks, such as the KN95, to be distributed quickly.
Notably, the KN95 is a standard Chinese mask with similar properties to the N95 in terms of blocking bacteria by at least 95%. When it was clear that governments were required to supply and were accepting the importation of the KN95, suppliers started importing this particular mask in huge quantities.
Isn’t the KN95 supposed to be a Medical Product? How come all the Packaging says Non-Medical.
The KN95 mask for COVID-19 is, in fact, both a medical and non-medical product, just like the N95, but it is a more complex explanation.
By its nature, the N95 is not typically used in a medical setting. Ask many doctors or dentists, and they may not have worn an N95, KN95, or similar product until the emergence of the coronavirus. Some may have worn one during the last SARS pandemic, but it is not usually a product used in a medical setting.
Due to the pandemic, although the N95 and related masks like the KN95 are meant for non-medical use, they have been temporarily allowed for sale and use within a medical setting. That is because of their ability to block 95% of bacteria known as BFE and particulate (PFE).
Starting July 1st, 2020, the restructured standard for the KN95 is GB2626-2019, what does that mean for my mask that says GB2626-2006?
In December of 2019, the Standardization Administration of China Standard modernized the KN95 masks’ standards for COVID. This standard for the KN95 is called GB2626-2019 and was to go alongside the GB2626-2006. The launch date for this is July 1st, 2020.
With this upgrade, there are some additional standards for the KN95 to meet. However, the GB2626-2006 is a valid KN95 standard and can be used safely. The GB2626-2006 is an approved standard that is recognized by the FDA and CDC.