Questions You Should Know about Kn95 High-Speed Mask Machine

• A new report finds that the popular KN95 masks are not as effective as N95 masks that have been in short supply.
• However, KN95 masks may have uses outside of high risk areas.
• Masks have been shown to be effective at limiting the spread of COVID-19.

A new report found signs that popular KN95 masks are not as effective as N95 masks.

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Researchers at ECRI found that up to 70 percent KN95 masks imported from China don't meet U.S. standards for effectiveness as with N95 masks. The group issued a hazard warning in September

Both products are said to filter 95 percent of aerosol particulates. KN95 respirators differ from N95 respirators because they meet the Chinese standard but are not regulated by U.S. agencies.

In the United States, the National Institute for Occupational Safety and Health (NIOSH) regulates masks.

'There's a potential misunderstanding in the public about the two masks,' Dr. Krutika Kuppalli, an infectious disease professor at Stanford University, told Healthline.

More importantly, though, ECRI is worried that doctors and nurses are using KN95s that are not filtering 95 percent of particulates.

A team at the not-for-profit patient safety group noted that 60 to 70 percent of imported KN95 masks do not filter 95 percent of aerosol particulates. ECRI tested about 200 masks from 15 different manufacturers.

Because health systems were purchasing some of the models tested, ECRI chose to raise an alarm and issue an alert to the public.

'Because of the dire situation, U.S. hospitals bought hundreds of thousands of masks produced in China over the past 6 months, and we're finding that many aren't safe and effective against the spread of COVID-19,' Dr. Marcus Schabacker, president and chief executive officer at ECRI, said in a press release. 'Using masks that don't meet U.S. standards puts patients and frontline healthcare workers at risk of infection.'

Schabacker hopes healthcare providers will be more critical of masks before purchasing masks.

Healthcare systems are still importing PPE due to widespread shortages. Hospitals report significant challenges ordering masks made in the United States. Some believe they are competing with the U.S. government as it seeks to replenish its PPE stockpile, ECRI said in a statement.

'We have seen a little bit of an ease up on the supply chain,' Schabacker told Healthline. Some health systems and hospitals are still having a difficult time getting PPE, he added.

A spokesperson at the National Personal Protective Technology Laboratory at NIOSH told Healthline that non-NIOSH-approved products should only be used in crisis situations when no other NIOSH-approved N95 respirator or a listed device from one of the other recognized countries is available.

In this case the KN95 masks would only be used as a last resort, although likely a step above a surgical mask.

In these cases, KN95s that meet the requirements of the Appendix A list from the Food and Drug Administration (FDA) can be used to protect workers during the pandemic, the spokesperson said.

Just because the KN95s may not meet NIOSH standards, however, doesn't mean they're useless.

'KN95 masks that don't meet U.S. regulatory standards still generally provide more respiratory protection than surgical or cloth masks and can be used in certain clinical settings,' Michael Argentieri, vice president for technology and safety at ECRI, said in a statement.

Schabacker said KN95s can be used in lieu of surgical or procedure masks for activities that involve limited contact with bodily fluids, as KN95s are not intended for fluid repellency.

But they should only be used as a last resort when treating patients with known or suspected COVID-19.

'Don't use KN95s at this point in high risk areas,' Schabacker said.

'Hospitals and staff who treat suspected COVID-19 patients should be aware that imported masks may not meet current U.S. regulatory standards despite marketing that says otherwise, Argentieri added.

There are many noncertified masks that have head and neck straps that can ensure air is being filtered, the ECRI statement said. These differ from those with ear loops.

This isn't the first time mask quality has come into question.

In May, the FDA reissued an emergency use authorization for non-NIOSH-approved disposable filtering facepiece respirators manufactured in China. It gave criteria for masks to be submitted to the FDA by the manufacturer or importer. It was already known that many respirators failed to meet the 95 percent filtration standard in testing conducted at NIOSH. A month later, the FDA revised criteria to show which respirators were no longer authorized.

A group out of Harvard and MIT known as the Greater Boston Pandemic Fabrication Team (PanFab) evaluated KN95 masks and published results in July. That report also supports the finding that many KN95 masks did not perform to the standards that they claim to meet and are likely to be counterfeit, said Deb Plana, a leader with PanFab.

They looked at masks donated to three hospitals in Boston.

Plana told Healthline that one counterfeit mask they studied even released more particles than were present at the input of the testing apparatus, which corresponds to a negative filtration performance.

That said, not all Chinese-made masks are problematic.

'Some masks marked as KN95s perform to accepted standards,' she said.

The group wants to see masks tested by federal regulatory agencies before they are distributed to healthcare practices, 'even in times of crisis,' Plana said.

Schabacker said his team was surprised to find that it wasn't one brand failing over another. Instead, some masks made by one brand worked and some didn't.

'That's even more concerning,' he said.

It's hard to say if you can trust the masks, as there 'doesn't seem to be a consistent QA [quality assurance] process,' he said.

ECRI will continue assessing masks to provide more insight on quality standards. They plan to look at KF95s, which are made in Korea.

'We're not saying this is all bad product,' he said.

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Schabacker estimates there are about 3,500 manufacturers making KN95s in China.

He emphasized that ECRI didn't do a representative sampling of masks made by all manufacturers.

While he hopes that some KN95s still live up to the standard, he said he is not sure. Meanwhile, people should check existing KN95s for certification.

'Try to get something from the vendor or have them tested so workers aren't at risk,' Schabacker said.

For information on how to evaluate KN95 respirators or those from other countries, consider reading these two articles from the CDC:

NIOSH's infographic highlights what people should look for when trying to determine if a respirator is NIOSH-approved.

A CDC report detailed mask tests from the FDA, and shares insight into buying devices not NIOSH-approved.

Plana recommends these tips to evaluate mask quality and see if an N95 is counterfeit.

1. Use trusted supply chains.
2. For filtering facepiece respirators claiming N95 certification, check for active and correct Testing and Certification numbers on the NIOSH Certified Equipment List (CEL) or the NIOSH Trusted-Source site.
3. Check for similarity to a fraudulent product on the NIOSH website.
4. For filtering facepiece respirators claiming compliance to a non-US standard (e.g. KN95s, FFP2s), check if masks are on the FDA Appendix A or Exhibit 1 lists of respirators authorized for importation under EUA. Also check the CDC Assessment Results for Not NIOSH-approved respirators for filtration performance.
5. Check for inconsistent markings. No FFP2/3, KN95, DS/DL, P2/3, or PFF product should bear a NIOSH stamp since NIOSH only certifies the U.S. N95 standard (the reciprocal is also true). A list of different respirator certifications by the nation is available at the CDC website.
6. Consider independently performing filtration testing in the absence of verifiable manufacturer information for a specific mask. This can be accomplished by submitting the mask for testing to a CDC- or a NIOSH-approved commercial facility (see the CDC International Respirator Assessment Request page). Some institutions may want to consider using their own testing apparatus, as described in the methods section of this paper.

As the new, highly infectious Omicron variant sweeps the nation and the world, public health officials have updated their guidance for masks and respirators.

The Abstract spoke to Bryan Ormond, assistant professor of textile engineering, chemistry and science at North Carolina State University and the Textile Protection and Comfort Center, about the difference between N95s, KN95s and KF94 respirators, what to think about when trying to choose between them, and what you can do if you can't find one.

The Abstract: Why are people talking about N95 masks now? 

Bryan Ormond: The Omicron variant is extremely transmissible; that's why people are talking about needing higher levels of mask performance. In some ways, nothing has actually changed in the guidelines or science; if your goal has been to provide yourself with the highest level of respiratory protection available, the filtering facepiece respirators (FFRs) like the N95 have always been the recommended option. However, when everything started in , we did not have the supply of these disposable respirators for the entire population to have steady access, and therefore, the recommendations were to reserve them for the people who needed respirator protection the most ' the health care workers, the immunocompromised, the sick. 

Since then, the supply chain for high performance FFRs has caught up. I recently went to a home improvement store and saw N95s on the shelf for the first time since March . And we don't just have one version of the N95s; we also have KN95s and other products that are similar in performance. 

TA: What are the differences between N95, KN95, and KF94 masks?

Ormond: The biggest difference in these is that they are tested and regulated by different countries. The N95 is the version that has been tested and evaluated to U.S. standards set by NIOSH, or the National Institute for Occupational Safety and Health. The KN95 is the version that meets the Chinese standard. The KF94 is regulated by South Korea's Ministry of Food and Drug Safety. 

These are all FFRs that provide the higher-end performance regarding respiratory protection for the wearer, but they also are very effective at limiting the spread of infectious particles. While they are all FFRs, it's important to realize that N95s, KN95s and KF94s are not automatically equivalent. You do see some regulatory differences as well as design differences. 

Both the N95 and the KF94 follow a rigorous test standard accompanied by a strong regulatory body overseeing their production. The KN95s have a similar test standard and performance requirements, but do not have the same level of regulatory oversight during production. 

These are going to be in the upper 90s in terms of the percentage of particles that they filter from the air you breathe, but they can vary significantly in terms of how difficult they are to breathe through. From a protection perspective, the ideal scenario is that everybody could have access to at least an N95. But at the end of the day, while the N95s and other respirators give you the most protection, the best mask is still the one you're going to wear consistently.

TA: How do they work? 

Ormond: These FFRs are typically going to be made of some sort of nonwoven filtration media. A nonwoven material can be thought of as a mat of fibers melted together. You don't get the same large holes or gaps between fibers or yarns in nonwovens that you see in woven or knit fabrics.

In terms of how they work, first there is the bulk filtration, where you're just capturing large things. The particles run into the fiber and are caught. In addition to this mechanical filtration, they also have electrostatic filtration. That means they have an electric charge that helps them capture smaller particles. That charge can wear out over time, which could decrease the overall filtration of the material. 

TA: What factors should you consider when choosing between them? 

Ormond: When you take and test these on a face, the fit will be different. N95s may not fit everybody's face. When we test N95s on our manikin head form, the head form is a little narrow for it. We don't always get 95%. Also, they are much more stiff. They don't conform as well. If you have a smaller face, you might get gaps and it might not work as well for you. So depending on your face shape, you could look at a KF94 or KN95. You're just trying to get one that fits you better.

TA: How can you tell if a mask is fake?

Ormond: People talk about counterfeit N95s or KN95s; it may not be that they don't work or that they are knockoffs, it may just be that somebody didn't pay to have them go through the certification process and is claiming that they are certified. There could be some that are made with materials that are not very good, so you have to be careful. 

If you want to check to see if your respirator has been identified as counterfeit, you can check the CDC's website that tracks the products that they have taken action on. If you want to check on the performance of a surgical or cloth mask, you can go to this website to see if your product has been submitted to meet the new standard for face coverings from ASTM International. The purpose of this list is to show the relative performance of products that have all been tested under the same conditions. It will tell you the amount of particle filtration and breathability of various products. 

TA: Is it still not OK to have an exhaust valve on your N95?

Ormond: When we tell people not to wear an N95 with an exhaust valve it's because it's an airborne infectious disease. If you're breathing out with it, you're spreading it, but protecting yourself. 

TA: How should people be cleaning N95s and other masks, and how long can we wear them before they need to be discarded or washed? 

Ormond: For N95s or KN95s, I wouldn't toss them in the washing machine. There's a chance you could lose the electrostatic properties as well as damage the materials. For the general public, I would use them for about a week and get another one. If the supply chain has caught up to where we think it has, then that's the benefit of these. If you have access to them and your goal is to protect yourself as much as possible, they're disposable, so get another one. 

TA: What if you don't have a KN95 or N95? What are some tips to increase the safety of our face coverings? 

Ormond: The most important thing with anything you wear is it has to fit your face. An N95 could give you 95 to 100% particle filtration, but if it doesn't fit your face, that's going to drop. If you want to go with the FFR like a KN95 or N95, you should try some different ones to make sure they fit. 

While they are not respiratory protection devices, surgical masks can still work really well. In our testing, we've found they can get between 40 to 70% in terms of respiratory protection. There are a ton of brackets you can buy for them to help them conform to your face. If you close down the sides, it's going to be harder to breathe through, but it will be filtering more. 

If all you have is a surgical mask, and you don't have access to the brackets, you can double-mask using a second cloth mask. The whole point of double masking is to make surgical masks fit better. That's going to get you a more optional performance in terms of protection.

It comes down to what you're able to do. If people can take one thing away from this it should be to make sure what you're wearing fits. 

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