What is the Kn95 Protection Level?

While Americans are being asked to use classical surgical-style face masks on the street, healthcare professionals on the frontlines of the Covid-19 battle require more extensive protection. Typically, American doctors and nurses have used N95 respirators, but recent shortages necessitated the importation of similarly-styled kn95 masks from China.

In theory, the k95 protection level should be the same as n95 masks, filtering at least ninety-five percent of particles. In reality, however, many of the Chinese masks have proved to be faulty, with some blocking as little as twenty-four percent of particles, far below United States’ standards.

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The kn95 Mask, in Theory

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In theory, the n95 mask and the kn95 are essentially the same thing. Both are “filtering facepiece respirators” used by hospitals to protect workers from infectious diseases. The only major difference is that the n95 mask is the American model while the kn95 mask comes from China. There are several types of filtering facepiece respirators, and other countries, like Korea and Japan, have their own models. There are some small differences between the prototypes for each specific mask, but they are negligible.

The kn95 mask, for example, offers slightly more inhalation resistance than the American n95 model. In the most important category, however, the kn95 mask and the n95 mask are meant to be the same: Both are purported to filter at least ninety-five percent of airborne particles.

It is the filtering capacity that allows doctors and nurses to trust the respirators. If a mask filters almost all particles in the air, then Covid-19 patients can be treated with limited risk of infection for the healthcare worker. Kn95 masks were said to have the same protection level as the n95 masks American hospitals were so desperate for. That’s why the Federal Drug Administration decided to approve the kn95 masks for use in the United States. It was believed that American healthcare workers were getting products they could count on.

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The kn95 Mask, in Practice

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When kn95 respirators were approved for use in American hospitals, imports began immediately. This is no surprise, seeing as the stockpiles of n95 masks had been seriously depleted. Around the country, hospitals and medical professionals brought in shipments of Chinese-made kn95 masks, produced by a variety of companies. Even the New England Patriots NFL football team sent a plane to China to pick up kn95 masks for Massachusetts hospitals. At the time, it seemed that the kn95 mask would be the savior for the American healthcare system.

Just a few weeks later, it became apparent that this optimism was sadly misguided. When they were initially imported, the kn95 masks were not tested by the F.D.A., but by accredited independent laboratories, many of which are located outside of the country. Supposedly, this vetting process assured that at least ninety-five percent of particles were filtered by the imported masks. To be sure of the masks’ protection level, the Center for Disease Control and the F.D.A. decided to conduct some testing on their own. The results were horrifying.

Of the specific kn95 masks that the United States government had previously approved for use, seven failed to prove that they filtered the required ninety-five percent of airborne particles. This means that doctors and nurses who had been using them had been at significantly greater risk of infection than they had previously realized. While some of the masks nearly made the ninety-five percent cutoff, others were horribly insufficient. One mask manufacturer, for example, had delivered masks with just twenty-four percent filtration capabilities.

The C.D.C. and the F.D.A. also tested some brands of masks that had never been approved in the first place, but nonetheless have seen frequent use in the United States. The results of these studies were even more appalling. One type of mask filtered only one percent of particles, a laughably low figure that exposes that particular respirator as an absolute sham.

How the F.D.A. Responded

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Once the defects were detected, the F.D.A. updated its list of approved masks. All the respirators that had failed the particle filtration test were removed from the list, meaning they can no longer be used in American hospitals. The agency also removed all masks that had not yet been tested, and put the obligation on manufacturers to get their products properly tested before they could be reinstated to the list.

There are some Chinese-made kn95 masks that passed the filtration test and remain on the list of approved respirators. These masks have proved their quality, and are just as effective as the American n95 masks, with ninety-five percent of particles removed. Indeed, these are the “true” kn95 masks that work as they are meant to. Remember, in theory, the kn95 masks should offer just as much protection as their American counterparts.

How Hospitals Have Been Affected

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Hospitals and healthcare facilities that ordered or received large numbers of the faulty kn95 masks now find themselves with stockpiles of personal protective equipment they can’t trust. With the well-being of care providers remaining the top priority, hospitals say they will not use the faulty masks. A Massachusetts hospital that received equipment from the Patriots, for example, has said the kn95 respirators will remain packed away.

Some have questioned the F.D.A.’s methodology in vetting the masks when they were first imported. It has been suggested that allowing accredited laboratories in China to complete the testing was always likely to lead to problems. While the need to rush the approval process was evident with American masks in short supply, there can be do denying that countless kn95 masks in American didn’t offer adequate protection.

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In theory, the kn95 mask offers the same protection level as the American n95 model (that is, ninety-five percent of particles are removed). In practice, however, many kn95 masks have proven to be well below F.D.A. standards. All the same, some brands of kn95 respirators proved themselves adequate after testing and remain in use in the United States. These tried and tested models offer sufficient protection for use in American hospitals.

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