KN95 Masks have been listed by the Center for Disease Control (CDC) as a suitable alternative when N95s are not available [1]. The US Food and Drug Administration (FDA) has also enacted measures to authorize Chinese KN95 mask suppliers and ensure their KN95 masks meet certain criteria for protection and authenticity.
Likewise, the FDA has also authorized non-NIOSH masks that met similar standards and are produced in other countries. This applies to non-NIOSH masks from Australia, Brazil, Europe, Japan, Korea, and Mexico.
NIOSH is the US standard for classifying and certifying respirator masks. In other countries, the CE standards of the United Nations are applied. There are some small differences between these certifications, but with supplies of NIOSH approved N95 masks dwindling, alternatives are needed.
KN95 masks are made of four materials layered together: non-woven fabric, electrostatic melt-blown cloth, cotton, and polypropylene (PP) cloth. N95 masks must be approved by NIOSH and meet the FDA’s 42 CFR 84 regulations. By contrast, KN95 masks may be CE certified and are manufactured to the Chinese Standard GB2626-2006.
China KN95 masks are being considered as “equivalent” to US NIOSH N95 and European FFP2 respirators according to the FDA’s Emergency Use Act. These types of masks (KN95, N95, and FFP2) are intended for filtering non-oil-based particles such as those resulting from viruses. They filter out approximately 95% of airborne particles that are as small as 0.3 microns.
The New York Times interviewed a Virginia Tech aerosol scientist and an expert in the transmission of viruses named Linsey Marr [4]. She explains that 0.3-micron particles are actually harder to catch than 0.1-micron particles in some cases because of the way the particles move in the air. Marr elaborates saying:
“...coronavirus is around 0.1 microns, it floats around in a wide range of sizes, from around 0.2 to several hundred microns, because people shed the virus in respiratory fluid droplets that also contain lots of salts and proteins and other things...”
There is a lot of talk about converting facilities like those of General Motors into respirator production. A report from NPR explains the many challenges of converting factories and takes a look at how masks are made.
Manufacturing masks involves several processes. In addition to making the facepiece, manufacturers need to make the straps and earloops, the metal nostril strips, and the packaging [3]. The biggest challenge producers are facing is a supply bottleneck of a once-obscure material called melt-blown fabric. This fabric is a very fine mesh made of synthetic polymers. It forms the inner filtration layer of the mask.
Melt-blown fabric fibers are very tiny, less than one micron in diameter [3]. Precision machines are required to make melt-blown fabrics. These machines cost upwards of $4.23 million each and after they are made they take about a month to set up properly. The shortage of fabric and difficulty expanding manufacturing is very problematic. In the short term, little can be done except push existing facilities to their maximum production capabilities.
Counterfeit N95 and KN95 masks are a major concern. If these were to make their way into a healthcare setting it would result in major risks of infection to healthcare workers. Surprisingly, fake N95 and KN95 masks are making their way to the US through Chinese drug traffickers. A shocking report from Vice explains:
“They're supplying [countereit masks] through the same exact supply chain, through the same exact marketing mechanisms, that they have with illicit drugs for a long time... ...the Trump administration’s efforts focused on seizing shipments of cocaine from Colombia and Venezuela — not going after the Chinese trafficking networks that have been supplying fentanyl and other synthetic opioids fueling the skyrocketing drug overdose death rate in the United States.”
While this means it will be harder for Mexican cartels to obtain drugs and drug ingredients, it also means that the black market has turned its focus to counterfeit masks and has an existing elaborate supply chain to distribute them.
Importing KN95 masks from China is a difficult process that requires extensive fact-checking. Counterfeiters are extremely skilled at creating fake products and fake documentation. However, the FDA has declared an Emergency Use Authorization (EUA) for KN95 masks from China.
To verify the authenticity of non-NIOSH-approved respirators like the KN95 mask from China, importers can check that manufacturers have met all of the criteria set out for them by the FDA’s EUA. This includes verifying that the manufacturer is registered in the FDA’s database.
Masks that have been authorized for use under the EUA can be found by searching the FDA’s database. In order to appear in this database and acquire authorization, respirator manufacturers are required to meet the following criteria. Importers must also meet their own criteria set out by the FDA.
The FDA has also released an updated list of approved Chinese respirator importers April 11, 2020, “Appendix A: Authorized Respirators” that offers a quick view of some of the non-NIOSH-approved respirator manufacturers. These manufacturers have met the FDA’s EUA requirements and are permitted to wholesale respirators to US importers and healthcare facilities.
Respirators eligible for authorization under this EUA are disposable non-NIOSH-approved respirators, like KN95 masks, manufactured in China [Stakeholders 2020]. They must meet at least one of the following criteria described by the FDA in their letter issued April 3, 2020:
Electronic Labeling
Manufacturers must publish the intended use and other instructions (such as fit testing, etc.) about all authorized models that are imported and authorized under this EUA on their website in English [5]. They must provide the FDA with the website address used to meet these criteria. The FDA will then make the information available on their EUA website.
Written Letters
Manufacturers must provide a letter, in English, that can be distributed to each end-user facility (e.g., each hospital, etc.) that receives the authorized respirator [5]. This letter must include the authorized respirator’s manufacturer, model, intended use, manufacturer’s webpage, etc.
Importer and End User Notifications
Manufacturers must notify the importers of the terms and conditions of this EUA and ensure that the end-user facility (e.g., each hospital, etc.) that receives the authorized respirators also receives the required written letter [5].
Adverse Event Reporting
Manufacturers of authorized respirators must have a process in place for reporting adverse events [5]. If a manufacturer becomes aware of an adverse event related to its respirators they must report this to the FDA.
Descriptive Materials
Printed descriptive materials relating to the use of the authorized respirators in the United States must be consistent with applicable CDC recommendations for use during the COVID-19 outbreak, as well as the terms set forth in this EUA [5]. Descriptive printed materials are prohibited from representing, claiming, or suggesting that the respirator product is safe or effective for the prevention of COVID-19.
Record Keeping
Manufacturers of authorized respirators must maintain any records associated with the EUA until otherwise notified by FDA [5]. Such records must be made available to FDA for inspection upon request.
Decontamination
Manufacturers of authorized respirators that are decontaminated by an authorized decontamination system are not responsible for any additional conditions that may apply to the manufacturer and/or operator of the decontamination system unless they are the same manufacturer [5].
When it comes to NIOSH approved masks, the CDC has published an extensive guide to identifying fake masks.
How to identify a NIOSH-approved respirator [2]:
Signs that a respirator may be counterfeit include [2]:
This is just one of the many images of counterfeit masks provided by the CDC. They explain:
“This is an example of a counterfeit respirator. Raxwell is not a NIOSH approval holder or private label holder. They are using Shanghai Dasheng Health Products Manufacture Co. Ltd’s (SDH) NIOSH approval number, TC 84A-4329, without their permission. (3/31/2020)”
The CDC has published this image of how to read the markings on a NIOSH-approved mask to help evaluate its authenticity:
There are some tests that consumers can do to ensure their face masks meet basic protection needs. Three simple methods are described below.
To do the lighter test, put on the mask and hold a lit lighter six inches away from your mouth. Try to extinguish the flame by blowing on it. Certified masks should not allow you to blow out the flame regardless of your efforts. Poor quality masks will allow the flame to be blown out.
A certified lab-tested KN95 mask has a filtration rate of at least 95% and is designed to filter out at least 95% of particles sized three microns or larger. Saccharine products like Sweet and Low are about seven microns in size.
If you pour out some Sweet and Low and try sniffing it with your mask on you should only be able to detect a faint fragrance. If the full strength scent is detectable, the mask may be insufficient at providing filtration.
If you hold your mask by the elastic bands and fill the masking cup with water there should be zero leakage. Water will leak from masks that are poor quality or lack necessary waterproof layers.
To look at the KN95 mask price, ten online sellers were evaluated. Most sellers price their KN95 masks as a ten pack, but some math was applied to consider other buying options. One trend that was noticed was that many KN95 mask sellers had “marked down” their prices from outrageously inflated prices. For these sellers, the sale price was used to calculate an average KN95 mask price.
We did not consider KN95 mask wholesalers versus retailers, shipping costs, and importation costs. Another factor that was not investigated was if these other sellers are providing real KN95 masks with required documentation to comply with the FDA’s emergency use act.
Here is how the average cost of ten KN95 masks breaks down:
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KN95 Mask Prices Online |
Average Price of 10 KN95 Masks |
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$59.99 for 10 |
$59.99 + $62.20 + $39.50 + $99.99 + $44.99 + ($17.90 x 2) + ($29.95 x 2) + ($11.99 x 5) + ($4.50 x 10) + ($6.58 x 10) = $537.32 / 10 = $53.73 for 10 KN95 masks |
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$65.20 for 10 |
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10 for $39.50 |
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10 for $99.99 (marked down from $399.90) |
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10 for $44.99 |
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5 for $17.90 |
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5 for $29.95 |
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2 for $11.99 (marked down from $19.99) |
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$4.50 each (minimum quantity 100) |
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$6.58 each (minimum quantity 10) |
The average price of ten KN95 masks purchased online was found to be approximately $53.73. By contact, Healthcare Unlocked sells KN95 masks for just $40.00 for ten. That is just $4.00 per mask. Healthcare Unlocked KN95 masks have all of the required paperwork to substantiate their legitimacy and comply with the FDA’s emergency use act.
Healthcare Unlocked is committed to providing real PPE at an uninflated price. Price gouging has been a major problem during the COVID-19 pandemic. Healthcare Unlocked imports KN95 masks at wholesale costs and passes on that savings to customers. Large quantity orders and orders for healthcare organizations are also able to get additional savings. Shipping is also free on all orders over $29.00, and economic flat rate shipping is available for smaller orders.
