In early 2020, the discovery and rapid spread of COVID-19 led many governments worldwide to mandate mask and respirator wearing. While some countries required only surgical masks, others required the usage of high-filtration respirators certified by local authorities.
The most common of these certifications is the now-famous N95 certification given by the National Institute for Occupational Safety and Health, NIOSH. This particular certification designates a respirator as a medical device by showing that it has met specific performance criteria.
While N95 is the most well-known standard, the European Union certifies respirators by a slightly different system, classifying masks as FFP1, FFP2, and FFP3. This standard is similar to the NIOSH rating system and shows that a device has passed a range of performance and quality tests.
However, earlier in the pandemic, an issue arose where both N95 and FFP2 respirators were in incredibly high demand. This led to shortages globally as production couldn't keep up - what had previously been a niche product was suddenly needed by everyone. This issue only grew as many countries mandated FFP2 certified respirators over conventional masks such as surgical masks.
Fixing this shortage of devices quickly became an international priority. As a result, many non-PPE companies changed their production to masks while PPE companies did their best to increase production. China led the charge to increase output, and between March and May in 2020, China produced over 70 billion masks (1).
China's local standard, KN95, was temporarily authorised for use within the U.S. In theory, the devices perform similarly to an N95 or FFP2 device. However, the FDA quickly revoked its emergency use authorisation due to discovered subpar-quality devices.
As companies rushed to keep up with this newfound demand, many began to bypass regulations and testing standards. Even more nefariously, some companies purposefully began to label their devices falsely. These counterfeit devices hit every market in the world and didn't meet the quality or performance standards advertised.
This issue was so widespread that hospitals, medical facilities, and government agencies fell prey to counterfeit devices (2). It's easy to see why - many of the devices are packaged identically to their quality-tested and officially-certified counterparts.
While the issue of counterfeit masks made headlines back in 2020, this problem has since fallen off the media radar. It's easy to think this problem has been solved since it's no longer publicised. However, this couldn't be further from the truth. Even in 2022, counterfeit masks and respirators are an incredibly prevalent problem.
A New York Times study done in November 2021 found that on Amazon, most KN95 respirators don't meet the performance (3) that the standard should imply. Unfortunately, the issue of counterfeit masks looks likely to continue into the coming years unless a much stricter stance is taken against devices that don't meet local testing standards.
In today's article, we want to look deeper at counterfeit masks. Firstly, what exactly has caused this problem to become so widespread. Secondly, do we need to be concerned about counterfeit respirators? Finally, we also want to discuss how to ensure that you are buying officially-certified and performant devices.
Why Are Counterfeit Masks so Prevalent?
It’s both easier and cheaper to produce substandard devices instead of officially-rated high-efficacy masks. As such, some companies have decreased their costs by creating masks that aren’t as capable as advertised.
There are two critical parts to this. Firstly, creating masks isn’t easy. It requires a procedure that needs highly specialised equipment that is extremely costly. Typical N95, KN95, and KF94 respirators rely on non-woven electret melt-blown filters. While this material is significantly more straightforward to produce now than in the past, it is still tricky.
What makes the process so difficult is not necessarily creating the filter media but ensuring that it performs. Lower quality manufacturers can produce filters that vary significantly in fibre circumference, length and density, and at times, even thickness. This randomness is the nature of non-woven filters.
However, this variance in each filter can mean that some manufacturers print filters from inconsistent filter media. For example, non-woven filter media is printed in large sheets that are then cut down to create hundreds or thousands of filters.
Unfortunately, this lack of consistency can lead some parts of the sheet to perform significantly better than others, leading to some devices filtering less than intended. Luckily, many manufacturers have figured out how to produce far more consistent non-woven filters.
The second issue is the certification process. While every certification body has different standards and requirements, they all have strict guidelines regarding TIL (total inward leakage), filtration, and pressure drop. These tests have fees, require a significant amount of time to undergo, and due to their strict guidelines, not all devices will pass.
With the time and money required to get officially certified, some manufacturers decided that they couldn’t wait and decided to label their devices falsely.
However, perhaps the easiest way to answer this question is to say COVID-19. Masks went from a very niche device required only by medical and industrial professionals to a daily necessity for hundreds of millions if not billions of people.
Of course, this led to what some companies saw as a lucrative opportunity. Therefore, many wanted to get involved due to mask production increasing enormously - China alone exported 224 billion masks between March and December of 2020 (9).
There was also a lot of confusion towards the beginning of the pandemic that can still partially be seen today. Along with mask shortages, this led many people, organisations, and governments to purchase substandard masks. While many countries are implementing stricter guidelines now, there is still a lot of confusion surrounding which masks are best and how they compare.
How Serious Is the Issue of Counterfeit Masks?
About 60% of KN95 respirators NIOSH evaluated during the COVID-19 pandemic in 2020 and 2021 did not meet the requirements that they intended to meet. (CDC)
It's fair to say that counterfeit masks pose a severe problem. While we are living with COVID-19, it's imperative to ensure that the devices we are trusting to protect us are doing that - protecting us.
Counterfeit masks are such a big issue because it's almost impossible to tell which devices are fake and which are legitimate. While there are ways to check, many people are unaware of how they can do so. This has led to many counterfeit masks penetrating the market. Before we discuss how to identify a fake mask, let's investigate exactly how big of a problem counterfeit masks and respirators currently pose.
The same New York Times study previously mentioned(3) also found that out of the top 50 KN95 masks on Amazon, only a handful live up to their claims. Considering that Amazon accounts for the vast majority of online shopping in the U.S, these devices are reaching the hands of millions.
3M has so far claimed over 50,000,000 (4) counterfeit respirators that were attempting to carry its branding. This reveals a whole new issue - not only are many KN95 devices not meeting their performance requirements but some popular (and official) devices are also being copied and sold. From this, we can identify two types of poor-quality masks:
Subpar Performance Masks: These masks claim to hold a certification but don't perform to the standard.
Counterfeit Masks: These masks are more devious. They will claim to be a mask or respirator that they are not. They tend to perform far worse than the mask they are ripping off.
Fake masks are so prevalent that even government agencies are getting caught up. For example, the State of Maine had two million counterfeit N95 devices seized by Homeland Security Investigations agents (5). With even government agencies falling prey to these fake devices, it shows just how big of an issue counterfeit masks and respirators are posing.
As high as 70% (8) of the devices tested by the CDC have been either substandard in performance or outright fake. With this incredibly high number of counterfeit devices on the market, it's more likely that an unaware buyer would purchase a fake mask instead of an officially certified, performant device.
On top of this, other factors make counterfeit masks a severe issue. When it comes to the spread of COVID-19, there are so many variables that we can't control. For example, ventilation, if others are wearing masks, if others are vaccinated and so on. Often, we can't even control if we need to visit crowded spaces or not for tasks such as supermarket shopping.
As such, ensuring that we are donning a performant respirator or face mask is one of the only ways to minimise exposure to COVID-19 in particular situations. Conversely, if we don devices that aren't capable, we leave ourselves vulnerable.
On a more personal level, counterfeit devices pose a unique problem. They can give us a false sense of confidence and perhaps even lead to an increase in exposure through this belief. While masks are by no means a certain method to protect ourselves from COVID-19, they are the best method we have, and they can instill confidence that we wouldn't have had otherwise.
Overall, counterfeit masks present a problem that has never been witnessed before. While changes are slowly being made and countermeasures are being put in place, there's no denying that these devices still pose a serious threat.
How to Avoid Counterfeit Masks
With all of this talk about how hard it can be to identify counterfeit masks, it might seem like there's no possible way to tell what's legitimate and what's not. Luckily, there are a few steps that we can take to ensure that we receive devices capable of their promised specifications.
With many disposable KN95 respirators that don't meet the certification standards, it's usually worth steering clear of KN95 rated devices altogether. While the KN95 standard tests masks thoroughly to see which devices perform best, there are too many devices out there that fake testing or claim to hold the certification when they don't. Further, it's often impossible to verify the authenticity of a KN95 mask.
Of course, some KN95 devices adhere to the standard, and these perform well. However, without digging into the information behind the devices, it's hard to identify which masks are legitimate and which are not. As such, avoiding disposable KN95 devices altogether is recommended.
Instead, where possible, try to purchase masks that follow the N95, FFP2 or KF94 standards. These standards have up-to-date databases that will allow you to verify if the devices are officially certified or not. In the next section, we will cover how you can investigate the authenticity of a mask or respirator for yourself!
The best way to increase your chances of getting a legitimate KF94, FFP2 or N95 device is to make sure that the mask is produced in Korea, the European Union, or the U.S, respectively. Domestic mask sales and exports tend to be more strictly watched, and devices coming from the country are far more likely to be authentic products. Of course, these companies can still make false claims; however, the vast majority of questionable masks are produced in China (3).
Another universal piece of advice for avoiding counterfeit masks is to skip large e-commerce platforms such as Amazon and eBay. Rather, try to stick to the original manufacturer’s website where possible - If you’re looking for dipsosable N95 devices, consider purchasing from 3M or Honeywell directly. This will ensure that you receive an authentic device from the company itself.
On top of this, you're looking at purchasing a reusable mask, make sure to check the manufacturer's website for their testing and certifications. If these aren't visible, find another reusable mask brand that does provide these documents. For example, on AirPop's website, you can find these documents in the help section.
Not all third-party certifications and test results can be verified easily. However, some testing bodies, such as BSI, allow the user to confirm that the certificates shown are correct and that BSI has carried out these tests. By selecting PPE and typing Strax as the company name, you will find proof of AirPop's tests.
AirPop's testing from TTTS can also be verified using the QR code located at the end of AirPop's GB2626-2019 (KN95) certification. This will take you to TTTS's website and allow you to verify the authenticity of the test results.
Unfortunately, mask testing and certifications are possible to forge. Luckily, many third-party testing laboratories include databases or verification methods that allow you to check if that company did carry out testing on that particular mask. If there is no easy verification method, it's also possible to email the testing body to very a certification. However, this can take extra time.
Identifying Legitimate Masks
N95
In the case of N95 devices, NIOSH has published a document showing the required labelling on every device. While the best way to prove the authenticity of a device is to check the CDC's database, knowing this essential labelling can come in useful.
All N95 devices are required to have a NIOSH name or logo present. This name should be in block letters that stand out amongst other markings on the respirator. The manufacturer's name or logo should also be present. If the manufacturer has a trademark or abbreviation, they may show that instead or alongside.
The mask should also state the filter designation (N95) and the TC approval number, following the TC-84A-XXXX format. Finally, the model number and lot number should be clearly labelled on the device's exterior.
If you encounter an 'N95' respirator without these marking, it's not legitimate. The CDC requires that ALL NIOSH-approved devices follow these strict labeling guidelines and anything without them should be avoided.
Also, a telltale sign that a device is not N95 is if it uses earloops instead of headbands. This is because all N95 devices are required to use headbands. Therefore, if you encounter a device using earloops, it's not N95.
KF94
KF94 devices are a bit harder to prove the authenticity of. This is mainly due to the language barrier, as most of these devices will have packaging in Korean. As with N95 devices, the best way to identify the authenticity of a device is through the MFDS website. However, some markings can indicate the authenticity of a device.
All KF94 approved masks must show the KF94 badge on the packaging. This badge is a blue and red circle with the KF94 marking inside. The packaging should also mention that it is approved by MFDS - since this will likely be in Korean, look over the packaging and see if the letters MFDS are present.
There should also be a clear product name and product code on the packaging. This code will follow a format similar to 202009299. Usually, this code will be present on the backside of each masks individual package (7).
FFP2
Image from BOHS (British Occupational Hygiene Society).
FFP2 devices follow a similar marking system to NIOSH-approved respirators. The exterior of each device should have markings indicating information relevant to the device. If a device lacks any of these markings, it is not an approved FFP2 device.
FFP2 devices should have four markings on the outside of the device. These are the CE marking (in the form of a four-digit code), the protection class (in this case, FFP2 NR or R), the number and year of publication of the European standard EN 149, and the manufacturer's name/identity and product name (6). These four markings are required on all European standard EN devices.
While these markings won't identify the most devious fakes, where the imitation is an identical copy of the original device, they will allow you to identify the most common counterfeit devices.
You can then check the four digit code against the European Commission's database. If the code is not included in the database, the notified body does not exist, and you should avoid the device.
Some independent testing bodies have published information in a database that can be searched here. However, it is worth noting that not all testing bodies are present in this database.
Conclusion
Over the past couple of years, counterfeit masks have gone from being a non-issue to a severe and prevalent concern. In 2019 U.S Customs and Border Protection seized 1,300 fake masks. In 2020, this number increased to 365,000. In 2021 this number increased to 2.1 million from January to March alone (10). This stark increase shows that counterfeit masks are a problem that we will be dealing with for a long time to come.
Luckily, there are ways to prove the authenticity of a device. Ideally, comparing the device vs the associated database is the best way to ensure you are not purchasing a substandard or fake product. However, the labelling on each type of mask can also provide a quick visual way to pick out most counterfeit devices. Remember that the most devious counterfeit devices may use these markings with fake numbers (or copy other manufacturers' test numbers). As such, using a database is always the best method to check for authenticity.
When it comes to reusable masks that have testing outside of N95, KF94, or FFP2 certifications, check the test reports that they do have and find if an associated database is available. For example, in the case of AirPop, both the BSI and KN95 certifications can be proven by the associated laboratories database.
Sources:
- https://www.nytimes.com/2020/07/05/business/china-medical-supplies.html
- https://apnews.com/article/government-investigation-n95-scam-1694ed85d6ef99cdb6662f67d823c271
- https://www.nytimes.com/2021/11/30/health/covid-masks-counterfeit-fake.html
- https://www.3m.com/3M/en_US/worker-health-safety-us/covid19/covid-fraud/
- https://www.ice.gov/news/releases/millions-counterfeit-masks-seized-during-operation-maine
- https://www.dguv.de/medien/ifa/de/akt/pdf/faq_check_masks.pdf
- https://overseas.mofa.go.kr/my-en/brd/m_21422/view.do?seq=110
- https://www.kvue.com/article/news/investigations/defenders/counterfeit-masks-still-a-problem-amid-omicron/269-34c3ebf7-a096-48ad-8b59-906d40255e67
- https://www.bloomberg.com/news/articles/2021-01-14/china-made-40-face-masks-for-every-person-around-the-world
- https://www.cbp.gov/newsroom/local-media-release/cbp-seizes-counterfeit-n95-masks