How to identify suspicious, fake or misleading marks & certificates with your KN95 respirator mask.

PLEASE NOTE: This article is being constantly updated as I receive new, accurate information about this on-going problem. 

Part 2 in a series about ordering quality respirators and masks during this crisis. In Part 1, I talked about how to identify counterfeit or low-quality KN95 respirators. At Global Empowerment Mission, we have been flooded with suppliers offering their KN95 respirators to purchase so that we can fulfill our donation requests. I have found that over 90% of the KN95 respirators were unacceptable because they were either counterfeit or labeled incorrectly. I have found another layer of deceit that I want to reveal to you: CE and FDA certificates.

AN ANALOGY
Let’s say that a Chinese organic dairy company wants to export its milk to Europe. So, the dairy company sends its organic milk to a company in Italy, that specializes in electronics certification, to get a CE. The CE certifying company in Italy examines the milk and says “it’s milk.” And now that Chinese dairy company advertises that it has a CE for its “organic” milk. However, that CE certificate said nothing about the “organic” quality of that milk.

CE Certificate of Compliance
The European Safety Federation has recently written the following statement:

Unfortunately, we (the European Safety Federation = trade association of suppliers of PPE) are informed by different sources about ‘certificates’ or other documents used as basis for CE marking of PPE (including FFP2/FFP3 masks and eye protection), while these ‘certificates’ have no legal value and can not be used as conclusion of conformity assessment. It is not clear if these documents have actually been issued by the organisations mentioned themselves or if they are fake.

There is a Declaration of Conformity when importing Personal Protective Equipment (PPE) into Europe. There is a specific conformity assessment procedure for PPE. The ESF has found that several CE institutes in Europe have issued CE certificates for PPE that are outside of the institutes that have this authority (INSPEC, INRS, and more). Here is the full list of accredited laboratories for face masks testing in the EU. The ESF has listed on its website the list of CE certificates and institutes that are suspicious or fake.

The majority of these unofficial PPE CE certificates testify that the KN95 respirators are EN149:2001+A1:2009, which is the code for “respiratory protective device.” However, this falls short in qualifying these respirators as FFP1, FFP2 or FFP3. 3M respirators are classified furthered as EN149:2001+A1:2009 FFP2 NR D, which indicates the FFP2 filtration quality of the respirator.

So what’s wrong with this? My problem is in the misrepresentation of these suppliers and vendors that their respirator mask has the same quality as an FFP2 (or N95) based on the suspicious or fake CE. A respirator is not an FFP2 unless it has the correct certificate of compliance from an authorized inspector.

FDA Certificate
I already talked extensively about the difference between FDA authorization and approval. I have a problem with these certificates above because it aims to fool the buyers and suppliers to think that this is an official FDA certificate. One certificate wasn’t even signed as seen above. Also, I don’t know if someone removed or added the text “Certificate of Conformity” on top. I’ve seen so many versions of these, I honestly don’t know which is a real MONLKA certificate. A company may actually test the KN95 for US N95 standards, but their certificate looks shady. I’m sure that the FDA would have some issues with them using the FDA logo on their certificate, twice.

Here is another certificate that states that “This certificate does not denote endorsement or approval”, yet there is a STAMP with “FDA APPROVED” on the same page. The certificate further states that “weda is not affiliated with the U.S. Food and Drug Administration.”

Suspicious KN95 101
Let’s go over everything that we’ve learned. Here is an example of a mask from a supplier.

This is a respirator that looks like a typical earloop KN95 respirator mask. The seal on the mask has an FDA logo (illegal), FFP2 (no proof), N95 (no proof) and CE EN149:2001+A1:2009 (accurate). The box also states N95, FDA, and FFP2 which are misleading. The FDA registration certificate that was supplied with this mask has the name Fuyang Kunlun Shoes, not Jusenyuan. if the mask suppliers are not currently on the list of FDA Authorized Imported, Non-NIOSH Approved Respirators Manufactured in China. The CE certificate of compliance is from ECM, which is on the list of suspicious certificates from ESF. The name on this certificate is also A compamy. So, I would reject to buy from this supplier and manufacturer based on the information given to me.

Just to be clear, I am not saying that ALL foreign masks or KN95 respirators are fake, misleading, suspicious, counterfeit or poor quality. There is the list of Authorized Imported, Non-NIOSH Approved Respirators Manufactured in China and the NIOSH-Approved Particulate Filtering Facepiece Respirators. My goal in writing this series was to do the following:
1. Protect the medical staff in the ICU and ER from faulty KN95, as they come in close contact with high-risk patients.
2. Inform the suppliers about laws and regulations regarding the KN95.
3. Point out the level of fraud and misleading behaviors that I have seen amongst the manufacturers and distributors.

Just as an additional warning, we just received a KN95 respirator that IS on the list of FDA authorized KN95. KN95 N9. The official KN95 respirator appears not to include an FDA logo on the box and mask. Is the one with the FDA marks a counterfeit? I have no idea, but we are NOT buying these KN95. Once again, on behalf of the medical providers, we thank you, the ethical manufacturers and suppliers, for your heart.