How to verify a legitimate KN95 manufacturer or supplier? Hint: Google
DISCLAIMER: This article is being constantly updated as I receive new, accurate information about this on-going problem. Also, we have started two websites where we have vetted authentic 3M and Honeywell respirators.
KN95RespiratorMasksForSale.com: Group Buy deal for respirators from factories in China (GROUPON for PPE).
PPEConnector.com: first online, open marketplace for qualified suppliers and end-users of authentic PPE
PPECertification.com: PPE background check and fraud alerts.
The PPE reseller market was turned upside down on May 7th, 2020. I witnessed many resellers, who hedged their money on importing KN95s that WERE on the old FDA Appendix A which authorized the import, lose their mind when the FDA dropped their KN95 in the NEW FDA Appendix A. When the CDC started publishing their testing results, it became apparent that the old FDA Appendix A had many manufacturers that failed the CDC tests. The media had a field day, including my friends at NYT. On that day, resellers realized that there are millions of boats bringing in KN95s that were worth less than before and panic ensued. Prior to May 7th, KN95s that were on the old FDA Appendix A could be bought FOB in China for $1.10 and sold CIF in the USA in bulk for $2.90. This week, some of the KN95s that were kicked off the list were sold for less than $1.90. Meanwhile, the prices for N95, NIOSH, and KN95s on the new FDA Appendix A skyrocketed. My friend in the business equated the PPE market to the stock market. Price also went up and down depending on what Fauci or Cuomo had to say every day.
How did this happen?
It became apparent to everyone that the FDA performed no testing on its own before listing a manufacturer in Appendix A. They even said this. So who screwed up in the supply chain that allowed the influx of fake KN95?
1 — Is the fault with the manufacturers producing bad KN95?
2 — Is it the fault of the Chinese testing facility and its testing standards?
3 — Is it the fault of the melt-blown fabric manufacturers that supply the material for the KN95 manufacturers?
4 — Or is the fault on us, who trusted all of the parties above?
Manufacturers
I’ve had many manufacturing brochures come to my emails. Some of them look official and polished with photos of a sterilized facility, while some of them look amateurish with photos of a facility that was obviously a makeshift PPE factory. There were manufacturers with names like DaddyBaby or King Year Printing And Packaging, which makes you wonder if one should be buying PPE from them. China has started doing its due diligence and ensuring that they regulate their factories and their output. Some suppliers have indicated that many of these “manufactures” are white labeling another factory’s KN95 as their own. However, nobody has found a single factory as the source of all the bad KN95s.
Testing facilities
Oddly enough, the old FDA Appendix A had CTT CO. Ltd. as an authorized manufacturer when it is not a respirator manufacturer, but a Chinese testing lab. I have gone through hundreds of Chinese testing reports by now. Most people don’t understand that KN95 is tested according to Chinese standard GB2626, while FFP2 is tested in the EU according to EU standard EN149, and that N95 is tested according to US standard NIOSH. Nobody has produced a smoking gun about any egregious action by a testing company. However, there have been many reports of falsified documents by suppliers (read my other post).
Meltblown fabric
The price of the raw materials needed to produce respirators has astronomically increased. This has increased producers using machines for other types of nonwoven fabric being converted to make the melt-blown fabric. USA Today has written a wonderful piece covering the problems with the substandard fabric in the marketplace.
Your lack of due diligence
As of the time of this post, 99 respirators were tested by the CDC and only 36 of them met the definition of KN95. No matter how hard we try, we can’t control what happens above us in the supply chain (raw material, manufacturer, testing). Also, I’ve seen escrow deals, lawyer to lawyer deals, and major government deals have bad outcomes. However, I believe that there are a few things that we should do to protect ourselves.
- Yelp or Angie’s List
- Get samples and submit for testing
Google
Yes. Google the manufacturer and respirator model name. I picked 24 of the worst performers in the CDC International Assessment Results and Google them to see if I can track down their official KN95 testing report.
Here is the list of companies where I was unable to find proof on Google or LinkedIn of the company’s existence, proof of them selling KN95, or their KN95 testing report. Some of these companies exist, but there is no concrete information about their KN95. For example, if you Google just the name of the company, sometimes, you’ll find the company info. However, if you Google [company] + [respirator model name] then you’ll find nothing. Also, my Norton antivirus flags some of these company websites as dangerous. I’m unable to find any trace of the KN95 testing report for the following companies that failed the CDC KN95 test:
Anhui RYZUR Medical Equipment Manufacturing Co., Ltd. KN95B
Changning Lingjiakang Protective Products Factory KN95
Dongguan Xianda Medical Equipment Co., Ltd. KN95
Garry Galaxy Biotechnology Co., Ltd. Respirator Mask With TruTone Technology
Guangdong Fei Fan Mstar Technology LTD Purvigor KN95
Guangdong Nafei Industrial Holding Co., Ltd. Efficient Nursing Protective Mask
Guangdong Shantou Machinery KN95 Mask
Guangdong Zhizhen Biological Medicine Co., Ltd. KN95 Three-Dimensional Protective Respirator
Guangzhou Huashan Biotechnology Co., Ltd. GF-Mask KN95 Mask
Guanyang Yuhan Textile Co., Ltd. KN95 Protective Face Mask
Hangzhou Senrunqing Technology Co., Ltd. KN95 Mask-C
Huizhou Zhongna Medical Technology Co., Ltd Anysound KN95
Jining Jianda Medical Device Technology Co., Ltd. PM2.5 KN95
King Year and Packaging Co., Ltd. Self-Breathing Filtration Particle-Preventive Respirator
Kuangye (Dongguan) Technology Co., Ltd. Geyou KN95 Environmental Protective Respirator
Ningbo Green Health Science & Technology Co., Ltd. KN95 Protective Mask
Ningbo Green Health Science & Technology Co., Ltd. KN95 Protective Mask
San Jiao JS95–01
Sinpup Health (Shenzhen) Co., Ltd. Face Mask KN95
Tongcheng Chengfeng Protective Equipment Co., Ltd. Wanhuizhong Anti-Dust Respirator
Zhejiang Kanghao Medical Instruments Co., Ltd. KN95 Respirator
Zhongshan Zhongxin Medical Technology Co., Ltd. Protective Mask
Two companies, Guangzhou Sunjoy Auto Supplies Co. and Zhongshan Cassiey Biotechnology Co. had testing reports online. It is unclear why they failed the CDC test when they passed in their own internal testing.
Obviously, the fact that many of these companies are in China and their website may be in Chinese hampers this search. However, if you are going to spend hundreds of thousands of dollars, then I’d like to believe that you’d Google the name of the company.
Dear, public. Please send me the missing testing reports if you have them.
Yelp or Angie’s List
If you are the type of person who will read the reviews on your hair salon or check the background on your plumber, then I’d like to believe that you would check on the previous deliveries of your KN95 supplier. In a rush to acquire PPE, I have found that many don’t. So, please ask your supplier for the list of previous shipments to do a proper background check. If they won’t give it to you due to an NDA, then walk away.
Get samples and submit for testing
This makes obvious sense but delays the final shipment. If your supplier won’t send you a sample, then walk away. You can find an independent lab or submit your respirator to the CDC for testing. The respirator above, by Guangdong Nafei, had a maximum filtration efficiency of 10.5% and a minimum of 1.1%. That’s terrible. However, you can even tell by looking at this photo that the respirator lacks quality. Imagine what you’d discover by actually touching it and performing a fit-test before you place the order of 1,000 respirators.
Even after you send your business partner to check on a factory in China, work with a reputable supplier, use escrow, get a lawyer, order an SGS inspection, and do the steps that I outlined, you still might get screwed over. It may be the fault of multiple parties in the supply chain, including our government which has been said to seize your shipment. And at the end of it all, everyone might just get fooled by a really good counterfeit. All I can say is that I’ve seen it all. And I feel for you. I’m praying that you will stay safe and sane through this crisis.
Jay Park MD
www.linkedin.com/in/jayparkmd/
P.S. We are launching an open PPE marketplace that connects qualified suppliers and buyers for authentic PPE. Beta opening soon!
P.P.S. Want more on COVID-19?
KN95 Part 1: How to Spot a Fake KN95 Respirator Mask from China.
KN95 Part 2: How to identify suspicious, fake, or misleading marks & certificates with your KN95 respirator mask.
Alternative Medicine Treatment for COVID-19? Zinc and Green tea.
Why Rapid COVID-19 Tests are “CRAPPY”.
