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These KN95 Respirators are made in China and were one of the original brands and company's recommended for medical use by the CDC/NIOSH in their Emergency Use Authorization on April 3, 2020. However, a month later on May 7th the CDC removed almost all of these Chinese manufacturers from their approved list and revised the EUA over concerns about counterfeits along with wavering quality standards and recommended testing. Meanwhile, millions of these "approved" masks had already been shipped to the USA or were already here and in use in hospitals across the country including inside COVID-19 wards at countless hospitals.
We had imported these masks under the EUA using the CDC's April 3, 2020 guidance. However, after the CDC changed their guidance we submitted 10 samples from our batch of masks to the CDC/NIOSH/National Personal Protective Technology Lab for particulate efficiency testing.
You can read the complete report here. But here is a quick synopsis. Not all of the samples we submitted met the N95 testing standard. Some passed and others did not. The range of the 10 samples extended from a low of 70.2% to a high of 98.4%, with an average in the mid 80s. The modified N95 NIOSH test was testing the efficiency of the mask in filtering out particles that are 0.3 microns in size. As an aside, these results would have passed the equivalent European Union Standard of FFP1 but were not good enough to pass the NIOSH modified N95 test.
What does this mean? It means that these masks are still far superior to surgical masks, cloth masks, and all other masks that are not N95s, but these fell short of meeting the rigorous N95 standard.
So what to do? If you are planning to use these for medical use in a hospital then you should not order these masks. These are no longer approved for medical use.
However, if you intend to use these for a non-medical use then these masks are still far superior to surgical masks, cloth masks, etc. and are perfect for use when going into grocery stores, using at work or anywhere in public. You also have real test results with these masks to evaluate. Any mask labeled N95 or KN95 is really questionable without proper batch test results per the CDC so buyer beware.
By giving you the actual batch test results of these masks, our intent is to give you complete transparency so you can make a decision.