Please note: This article will continue to be updated as I receive new and accurate information about this ongoing issue. In addition, we have opened two new websites: KN95RespiratorMasksForSale.com: Group purchase of respirators, due to genuine PPE purchased directly from Chinese factories (PPE is GROUPON). PPEConnector.com: The first online open market for qualified PPE suppliers and end users. PPECertification.com: PPE background checks and fraud alerts.

Part 2 of a series of articles on ordering quality respirators and masks in this crisis. In Part 1, I talked about how to identify counterfeit or inferior KN95 respirators. In the Global Empowerment Mission, we are flooded with suppliers who provide KN95 respirators for our purchase so that we can meet our donation requests. I found that more than 90% of KN95 respirators are unacceptable because they are either counterfeit or incorrectly labelled. I found another layer of deception and I want to reveal to you: CE and FDA certificates.

By analogy, suppose a Chinese organic dairy company wants to export its milk to Europe. Therefore, the dairy company sends its organic milk to an Italian company specializing in electronic certification to obtain CE. The Italian CE certification company inspects milk and says "it is milk". The Chinese dairy company now advertises that its "organic" milk has obtained CE certification. However, the CE certificate does not state the "organic" quality of the milk.

CE Certificate of Conformity The European Safety Union recently wrote the following statement:

Unfortunately, we (European Safety Union = PPE Suppliers Trade Association) have learned from various sources the "certificates" or other documents used as the basis for the CE marking of PPE (including FFP2/FFP3 masks and goggles), and these "certificates" have no law Value cannot be used as the conclusion of the conformity assessment. It is not clear whether these documents were actually issued by the organization they mentioned themselves or were forged.

There is a declaration of conformity when personal protective equipment (PPE) is imported into Europe. PPE has a specific conformity assessment procedure. ESF found that several CE organizations in Europe have issued CE certificates for PPE, and these certificates are not outside the organizations that have this authority (INSPEC, INRS, etc.). The following is a complete list of EU-approved mask testing laboratories. ESF has a list of suspicious or forged CE certificates and institutions on its website.

Most of these unofficial PPE CE certificates prove that the KN95 respirator complies with EN149:2001 A1:2009, the code for "respiratory protective equipment". However, this is not enough to classify these respirators as FFP1, FFP2 or FFP3. 3M respirators are further classified as EN149:2001 A1:2009 FFP2 NR D, which represents the quality of the respirator's FFP2 filtration.

So what's the problem? My problem is that these suppliers and suppliers misrepresent that their masks are of the same quality as FFP2 (or N95) based on suspicious or counterfeit CE. The respirator is not FFP2 unless it has the correct compliance certificate from an authorized inspector.

FDA certification I have discussed extensively the difference between FDA authorization and approval in the previous blog post. I have questions about the above certificates because they are designed to deceive buyers and suppliers into thinking they are official FDA certificates. I was cheated the first time I watched it. Until you read it, you find that the certificate comes from a Chinese company called Shenzhen Menglanka Technology. As shown above, a certificate is not even signed. Also, I don’t know if anyone has deleted or added the words "Certificate of Conformity" at the top. I have seen so many versions, honestly I don't know which is the real MONLKA certificate. Shenzhen Monlka Technology may actually test KN95 according to the US N95 standard, but their certificate looks very dark. I am sure that the FDA will encounter some problems twice using the FDA mark on their certificate.

This is another certificate, which says "This certificate does not indicate recognition or approval", but there is a seal with "FDA APPROVED" on the same page. The certificate further states that “Weda is not affiliated with the US Food and Drug Administration.”

Suspicious KN95 101 Let's review everything we learned. The following are examples of masks provided by the supplier.

This is a Jusenyuan respirator, which looks like a typical ear-hook KN95 respirator mask. The seal on the mask has the FDA mark (illegal), FFP2 (no certification), N95 (no certification) and CE EN149:2001 A1:2009 (accurate). The box also illustrates the misleading N95, FDA, and FFP2. The FDA registration certificate attached to this mask says Fuyang Kunlun shoes, not Jusenyuan. Fuyang Kunlun Shoes and Jusenyuan are currently not on the list of FDA-authorized imports and non-NIOSH-approved respirators made in China. The CE compliance certificate comes from ECM, and it is in the ESF's list of suspicious certificates. The name on this certificate is also Fuyang Kunlun Shoes, not Jusenyuan. Therefore, based on the information provided to me, I refuse to purchase from this supplier and manufacturer.

To clarify, I am not saying that all foreign masks or KN95 masks are counterfeit, misleading, suspicious, counterfeit or inferior. There is a list of authorized imported, non-NIOSH approved respirators and NIOSH approved particulate filter respirators made in China. My goal in writing this series is to do the following: 1. Protect medical staff in the ICU and ER from the malfunctioning KN95 because they are in close contact with high-risk patients. 2. Inform the supplier about the laws and regulations of KN95. 3. Indicate the extent of fraud and misleading behavior I have seen among manufacturers and distributors.

As an additional warning, we have just received a KN95 respirator, which is on the KN95 list authorized by the FDA: Dongguan Arun Industrial Co., Ltd. KN95 N9. The official Arun KN95 respirator does not seem to contain the FDA mark on the box and mask. Are FDA-marked products counterfeit? I don't know, but we don't buy these KN95. By the way, Dongguan Yarun Industrial is a consumer electronics company.

Once again, we, on behalf of medical service providers, thank you, ethical manufacturers and suppliers, and thank you for your heart.

PS Want to learn more about COVID-19? KN95 Part 1: How to find fake KN95 masks from China. Alternative medications for COVID-19? Zinc and green tea. Why the rapid COVID-19 test is "crappy". How to verify legitimate KN95 suppliers?

PPS If you want to help our medical providers in New York City provide masks and protective clothing, please donate to the Bstrong Initiative of Global Empowerment Mission.

PPPS Thankfully, the Chinese Ministry of Commerce recently started cracking down on its own exports based on the guidelines I outlined. 4/19/20

KN95RespiratorMasksForSale.com: Group purchase of respirators, due to the purchase of genuine PPE directly from Chinese factories (PPE is GROUPON). PPEConnector.com: The first online open market for qualified PPE suppliers and end users. PPECertification.com: PPE background checks and fraud alerts.