Since March, I’ve been working with Bstrong and GEM to help authenticate the quality of the KN95 (N95 equivalent from China) respirators. I appreciate everyone’s heart and effort during this crisis by providing us with their export distributors in China. HOWEVER, I am finding that over 90% of the products being offered to us are NOT real N95 equivalent respirators. Since many of you do not know about the FDA regulations and why medical providers need high-quality N95 respirators, please let me guide you.
Outline:
1. Why high-quality N95 is important.
2. Difference between FDA registration and FDA approval.
3. Why the FDA logo on the box means NOT FDA approved.
4. Spot FAKE Chinese KN95/NIOSH/N95 knockoffs.
5. Lower-quality KN95 has earloops.
6. About N95/NIOSH/KN95 international performance standards.
7. Is Dasheng NIOSH a counterfeit or manufacturer error?
8. You might kill a medical provider by giving them a bad respirator.
9. 4 easy ways to help spot a low-quality respirator.
Low vs High-quality N95, NIOSH, KN95
Imagine that your face is a bank vault, the mask is a bank vault door and the virus is a thief. The door should be as thick as possible to reduce the possibility of a thief going through the door (N95 means 95% filtration). However, the SEAL of the door on the door frame is equally important. If there is a large gap between the vault door and the vault door frame, then the thief can easily get inside the bank vault.
Most suppliers don’t know this, but 3M respirators that are FDA-cleared have different sizes. It is NOT a one-size-fits-all. Furthermore, all hospital employees undergo fit testing to ensure a tight seal. The majority of the KN95 have earloops which creates a looser seal. While these respirators may have proof of testing of KN95 grade quality in China, this is the test of just the respirator (the vault door) and NOT the seal (door frame). We have already imported several of these low-quality respirators and have found that the fit is poor and the elastic is too loose to pass a hospital fit testing. Many of us using N95 respirators are face to face with coughing or vomiting patients. We want quality respirators with the tightest seal and not any respirator that will let the thief into the bank vault. This is why many health care workers have a mask-shaped bruise or line on their faces.
FDA registration vs. approval
The phrase I hear from suppliers is that their KN95 is FDA approved (RED-FLAG).
1. FDA doesn’t approve N95 respirators. It is a class 2 device that only requires FDA clearance. Even 3M, the official N95 for hospitals, does not use the word approval, but FDA-cleared.
2. On March 28th, the FDA issued an Emergency Use Authorization. This authorization allowed the manufacturer to seek a EUA to market in the US. However, not ALL KN95 was authorized for use. Here is the list of KN95 that are Authorized Imported, Non-NIOSH Approved Respirators Manufactured in China as per the FDA. However, on May 7th, the FDA removed 65 manufacturers from this appendix A, after the CDC testing revealed that majority of the KN95 on this list did not meet N95 equivalence. Over 100 KN95s were removed from the EUA by the FDA in one day because most KN95s were low-quality. [Updated 5/14/20]
3. If you import fraudulent masks from China and mislead a hospital, then you are NOT immune from liability. The HHS issued a declaration to provide liability immunity for claims against the distribution of PPE. However, it does not cover you from claims involving “willful misconduct.” Knowingly distributing fraudulent KN95 probably puts you in the “willful misconduct” category. Therefore, you have been warned.
4. Your FDA certificate is likely an FDA registration certificate and not an FDA approval. FDA has a TWO step process where ANY company can REGISTER their product with the FDA before getting clearance or approval. This registration certificate is given to a company that paid the FDA fee to get registered. The registration certificate states the following:
“Registration of a device establishment or assignment of a registration number does not in any way denote approval of the establishment or its products. Any representation that creates an impression of official approval because of registration or possession of a registration number is misleading and constitutes misbranding.”
Many companies will try to mislead you to believe that their KN-95 is FDA-approved by submitting an FDA registration certificate as proof. Once again, FDA registration is NOT FDA approval.
FDA logo on the box
FDA does NOT allow a vendor to put the FDA logo on the box of a respirator. So, if your Chinese KN95 respirator has an FDA logo on the box, then you are probably importing a non-authorized KN95 respirator. This is the easiest way to help spot a KN95 that is NOT FDA approved. Let me say this again: If the box or the label has an FDA logo, then it is DEFINITELY NOT FDA APPROVED. Thankfully, the Ministry of Commerce in China has recently started to crack down on its own export along with the FDA guidelines. For example, many suppliers have told me that China has forbidden the export of Dasheng respirators on the counterfeit list.
Counterfeit Chinese NIOSH respirators
The Chinese are notorious for exporting counterfeit goods. Unfortunately, it is no different when it comes to NIOSH(NIOSH is similar to N95). There are REAL Chinese NIOSH respirators being copied into counterfeits. Even the CDC has set up a webpage showing the difference between real and fake NIOSH respirators from China. If your respirator is on this list, then it’s fake and you are a participant in distributing counterfeit products. The CDC has also set up a webpage with the list of its NIOSH-approved respirators. Europe has also set up a similar website.
Lower-quality KN95 have ear loops
These are examples of the FDA-cleared N95 respirators from 3M.
Do you notice the elastic bands? They all WRAP COMPLETELY around the head!
Here are the low-quality KN95 respirators.
Do you notice the elastic bands? They all LOOP around the ears!
The difference in the elastic is in the analogy about the bank vault door and the door frame seal. We’ve tested many of these “ear loop” respirators and they are NOT tight enough. People have different ear sizes and distances from the face to the ear. While the quality of the respirator material may provide 95% filtration, the seal is inadequate to pass the fit testing on most medical providers. Most KN95 ear loop respirators might be adequate for civil use, but the seal may not be good enough for medical use.
Since publication, I have been accused of ignorance, because the “KN95 experts” tell me that “ALL KN95 HAVE EAR LOOPS.” I am no expert on this, I agree. But, I have attached an image above to show everyone that there are companies making higher-quality KN95 with headwraps. The result of the fit testing for these higher-quality head wrap KN95 is better than the lower-quality earloop KN95. [Updated: 5/14/20]
Know your N95 equivalent
We recently received a shipment of official European 3M FFP1 respirators from a vendor who misleadingly said that they were N95. Different countries will use different labeling to indicate similar functions. FFP1 respirators filter up to 80%, therefore they are NOT N95 equivalent. The closest European equivalent of N95 is FFP2 & P2 grade respirators, which are rated at 94%.
Also, different respirators are manufactured for different standards. If a KN95 is manufactured under Chinese GB2626–2006, then it can not automatically advertise that it is an FFP2 or NIOSH, as it is not always manufactured under other performance standards.
N95 (United States NIOSH-42CFR84)
FFP2 (Europe EN 149–2001)
KN95 (China GB2626–2006)
P2 (Australia/New Zealand AS/NZA 1716:2012)
Korea 1st class (Korea KMOEL — 2017–64)
DS2 (Japan JMHLW-Notification 214, 2018)
What’s up with Dasheng NIOSH? [Updated 5/14/20]
I have been getting angry responses and LinkedIn messages about this. I was told by a few Chinese suppliers that the “counterfeit NIOSH” or earloop KN95 seen in the header photo is also made by Dasheng. It should be noted that Dasheng does make official NIOSH respirators, but the real NIOSH Dasheng respirator’s elastic wraps completely around the head. I was skeptical that DTC3X has different styles until I saw the Dasheng DTC3X-1, DTC3X-2, DTC3X-3, DTC3B-1 appear on the list of FDA Authorized Imported, Non-NIOSH Approved Respirators Manufactured in China. The CDC later wrote this smoking gun about this product which states that it is an earloop respirator from Dasheng. A journalist from WSJ who contacted me also came to the same conclusion. Neither of us has had any luck in getting an official reply from Dasheng.
My current conclusion is that Dasheng makes both the official NIOSH respirator and the KN95 respirators that have been mislabeled on the box as NIOSH. The CDC lists these as counterfeits because A) they might be counterfeit, or B)Dasheng respirators that are mislabeled by the factory and they won’t admit this. It should be noted that these Dasheng counterfeit/mislabeled KN95 are really good quality respirators according to the CDC test result.
A trusted supplier has told me that Dasheng has changed the packaging. Dasheng was making the old KN95 style earloop design DTC3X with this new box up until April 2020. As of May 2020, Dasheng no longer makes earloop style DTC3X. How can you tell the difference between earloop Dasheng DTC3X made in April versus headwrap Dasheng DTC3X made in May? He says that you can’t tell by the box, but you have to open it up and look at the respirator. [Updated 5/14/2020]
A heart without knowledge is foolish
I truly believe and hope that many of us are stepping up to the call and providing our front-line medical staff with proper PPE. I understand the dire need as some of us are using garbage bags as additional PPE. But please understand that while something might be better than nothing, the way we interact with patients while using an N95 respirator is different than a simple surgical mask. Your importing of fake or lower quality respirators may cause one of my colleagues to die from the lack of proper protection. So, if you already imported fake KN95 or NIOSH, then tell the hospitals and providers about what they actually are. They can probably be used in non-high-risk settings. But, if you withhold this knowledge, then you are probably engaging in “willful misconduct.” READ: How To Spot Fake surgical Instruments and Medical devices
Conclusion: How to spot a counterfeit or low-grade N95/NIOSH/KN95 respirator mask.
FDA logo on the box
FDA registration certificate as proof of “FDA approval”
Earloops
Loosely packed masks without any packaging or labeling
Please don’t take this post as an attack on China. It is not. The world needs the manufacturing abilities of China. China also needs us. We are all in this together. On behalf of all the medical providers worldwide, we thank you, the ethical manufactures and suppliers, for your heart and effort.
Sincerely,
Jay Park MD
