The ongoing COVID-19 pandemic proved that no one, not even the richest countries in the world were prepared for this. Even the US and other first-world countries were caught off-guard with how serious this global health issue would become. In fact, as of this writing, the United States leads with the world with Coronavirus cases. What’s worse, healthcare workers on the front lines are running out of essential PPE supplies and looking to import many of the needed items. One of the most sought after items are N95 respirator masks from China.
However, ordering overseas can sometimes prove to be easier said than done. China not only has a history of providing inferior goods and fake/copy products, but also some suppliers will go so far as to create fake licenses and testing certificates to get orders. So, anyone in need of these products needs to be cautious.
A month or so ago we were approached to have our staff in China find reputable factories that produce the KN95 and N95 masks, as well as other PPE, and begin importing them. Although we’ve been importing various products from China since 2011, medical PPE were new to us and we had to ramp up quickly to fill demand.
It was a fascinating process. In a short period of time over 4,000 Chinese factories became mask producers, and many were claiming they had various certifications that they in fact did not have. We learned a great deal.
The purpose of this blog is to provide some insight on disposable respirator masks and some due diligence actions you can take to make sure you’re getting quality products from a reputable supplier.
Overall, there are two main brands of disposable masks coming out of China: the KN95 and the N95/FFP2.
But first we’re going to discuss a true American made N95 respirator mask.
A true N95 mask is made to 3M’s specifications. And at first glance the N95’s being manufactured by non-approved 3M facilities, may look and feel just like the original. However, even the slightest variation in the make up can render an N95 as not effective.
To prove their authenticity and effectiveness, an N95 manufacturer either in the U.S or abroad will need to gain a 510(k) clearance from the FDA before these masks can be marketed and sold in the United States. One of the key pieces of information the FDA will need to see is that the respirator masks have been tested by the US National Institute of Occupational Safety and Health (NIOSH) and has successfully passed.
An N95 mask provides aerosol filtration of at least 95%.
As stated, the N95 is an American brand. Well, in China, they have their own standard respirator mask called the KN95.
The China branded KN95 specifications are almost identical to the American N95 standard respirator mask (see table below). However, we found the feel and overall comfort to be less than the N95.
The China made KN95 are also subjected to testing standards similar to our NIOSH, but there are called Guo Bio (GB). Again, these are very similar. A KN95 that passed GB testing will have it’s own GB reference number stamped on the mask. Depending on the mask type it will either be GB2626 or GB19083.
Prior to the COVID-19 outbreak, the FDA did not allow these masks to be imported and used as a replacement for the N95. However, this doesn’t mean it was because they were less effective. In fact some believe it was more politically motivated rather than quality motivated.
Yet, as of this writing, the US FDA recently allowed the purchase and selling of the KN95 mask. This will depend on whether the suppliers and manufacturers meet the needed standards. It is also important that the imported KN95 masks are authentic.
In fact, even the Centers for Disease Control and Prevention said that these masks can replace N95 masks in case of the latter’s shortage.
This is where things can get a bit more hairy when sourcing N95 respirator masks overseas.
As I mentioned above, true N95 respirator masks from China will be NIOSH tested and both the company and their devices with be approved with the FDA.
Yet, anyone sourcing masks from China will see N95 and FFP2 masks being sold. So, are they authentic or simply copies?
The answer is it depends? First off, there are some Chinese medical manufacturers that are FDA and NIOSH approved. However, these are very few and far between. And of course there are those who are creating phony masks.
There are two places you can check a manufacturers legitimacy before purchasing an N95 respirator mask from China.
The vast majority of respiratory manufacturers are manufacturing masks as either an FFP2 or an N95 FFP2 mask. This is where it becomes tricky for the inexperienced buyer. It all comes down to testing. This determines the true quality and grade of the mask.
In addition to China’s GB testing and the United States NIOSH testing (mentioned above), Europe has their own testing standards called European Norm (EN). The EU classifies their respiratory mask testing into 3 FFP categories: FFP1, FFP2, FFP3. Click here for a more detailed explanation.
The difference is in the aerosol filtration. An FFP1 filtration rate of at least 80%, FFP2 is at least 95% and the FFP3 is at least 98%. And N95 respirator mask is equivalent to Europe’s FFP2.
This is how the Chinese are branding masks. Either through their own GB testing that will show as either GB2626 or GB19083 for sterile masks, or using the EN standards. For respirator masks that will be EN14983. It’s important to note that many more Chinese medical companies have registered and received CE approval and therefore test to EN standards and manufacture their masks to those specifications and label them as N95 FFP2.
However, there is another factor respirator manufacturers test for and that’s the bacterial filtration. Although bacterial filtration efficiency is normally reserved for surgical masks, many of the product tests we see include this. Without getting into too much detail, there are three levels of protection that are either shown using U.S ASTM standards of level 1, 2, 3 or EN standards of Type 1 or BFE1 (greater than 95%), Type 2 or BFE2 (greater than 98%), and Type R.
Below is a chart comparing the three respirator masks.
3M put out a tech sheet that covers the above in much greater detail.
According to the FDA agent we work with, the FDA has waived registration and listing requirements for some masks. So that can set up a slew of unscrupulous manufacturers selling inferior masks in the marketplace. We found a couple of things you can do to make sure you are buying from a reputable manufacturer.
We hope this shed some light on buying N95 respirator masks from China. As always, it’s so important that you do your research on any company offering N95 respirator masks, FFP2 or even the KN95 respirator masks.
As with any overseas purchase, there is always a sense of risk. However, if you follow our suggestions, you will greatly minimize any risk.
If you’re in the healthcare field, or with a Government office and do not want to put that time into sourcing overseas, feel free to contact our company. We are consistently importing different respirator masks and other PPE. We are sure to be able to get you what you need.
To purchase lots or 5 or 10 KN95 masks, visit our ordering page
For more information, please email us at email@example.com.
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