UPDATED: FDA bans use of some KN95 masks weeks after failed testing

The U.S. Food and Drug Administration has banned faulty masks from 65 manufacturers, according to a new report from the New York Times.

The move comes three weeks after evidence from another federal government agency suggested that these N95-style masks were ineffective against the coronavirus. These masks, known as KN95 masks, were produced in China and millions of them have been bought or donated to American hospitals for healthcare works on the front line of the COVID-19 pandemic, the NYT found.

“Due to the incredible demand for proper masks, many dentists and other healthcare facilities have been forced to go outside their normal supply chain and pay greatly inflated prices,” said Dr. John Flucke, Dental Product Report’s chief dental editor. “Now the realization that they were counterfeit is even worse. This situation will have repercussions on down the line in ways we may not have even thought of yet.”

The Centers for Disease Control oversaw testing of KN95 masks beginning in mid-April, the results of which found that some of these products do not meet medical standards for protection against the coronavirus.

However, it wasn’t until May 7 that the FDA banned more than 65 of the 80 authorized manufacturers in China from exporting KN95 masks to the U.S.

“There is no excuse for allowing front line providers to treat patients with deficient PPE,” Dr. Flucke said. “Healthcare workers, due to the very nature of our jobs, are putting ourselves at risk and allowing us a false sense of security that we have the best PPE available borders on criminal.”

“While the F.D.A. continues to take action to balance the urgent need of supplies of respirators for health care personnel, we are also doing everything in our authority to ensure health care personnel receive adequate protection,” an FDA spokeswoman said in a statement. She added that the agency would collaborate with the CDC to increase the supply of masks and ensure their integrity, according to the Times.

Due to shortages of much-needed N95 masks, many of which are produced in China, the FDA began to allow imports of similar-style masks on April 3, many of which are also from China.

“As a doctor, when I order PPE, I have to have confidence that the items will protect my patients, my team, and myself,” Dr. Flucke said. “This profiteering over a pandemic that has killed tens of thousands is almost beyond belief.”

The KN95 masks were required to be tested by an accredited test lab, which doesn’t have to be in the U.S., but were not required to be tested by American regulators. The CDC standard requires these masks to filter out 95 percent of particles that are 0.3 microns or larger, and the accredited test lab found they met that standard.

The CDC and the FDA began their own review as a precaution, and the FDA announced May 7 that too many of the masks failed to filter out an adequate percentage of particles. Of the roughly 11 masks that the FDA approved for sale directly to U.S. hospitals, seven failed testing. In one test conducted by the CDC on April 15, one mask filtered as little as 24-35 percent of particles.

“Dentistry has been suffering from a tremendous lack of guidance through this pandemic from government agencies,” Dr. Flucke said. “As if that isn’t bad enough, now comes word that, while certain divisions of the federal government knew of this problem, they failed to notify those that set the clinical guidelines.”

Many of these tests were conducted weeks ago, according to the Times article, yet the FDA didn’t remove approval of these masks until this week. It’s unclear why there was a delay or how many of the faulty masks were sold to American health care workers, where the faulty masks ended up, or if the U.S. government was tracking that number, the Times said.

5/13 Update:

On May 7, the FDA banned the use of KN95 masks from more than 60 manufacturers in China. Only 14 manufacturers remain on the FDA’s list of authorized imported masks. 

The list of FDA approved respirator manufacturers includes:

• 3M
• AOK Tooling Ltd. (AKA Shenzhonghai Medical)
• Bei Bei Safety Co Ltd.
• BYD Precision Manufacture Co. Ltd.
• Fujian Kang Chen Daily Necessities Co, Ltd.
• Guangzhou Harley Commodity Company Limited
• Guangzhou Powecom Labor Insurance Supplies Co., LTD
• HeiQ Materials AG
• Hangzhou San Qiang Safety Protection Products Co., Ltd.
• Rizhao Sanqi Medical & Health Articles Co., Ltd
• Shanghai Dasheng Health Products Manufacture Company, Ltd.
• Suzhou Bolisi Medical Technology Co., Ltd
• Suzhou Sanical Protective Product Manufacturing Co., Ltd
• Weini Technology Development Co., Ltd

The National Institute of Occupational Safety and Health (NIOSH), a subsidiary of the Centers for Disease Control, performed testing of imported KN95 tests last month. Testing found that roughly 65 manufacturers’ products performed well below the CDC’s standard filtration efficiency (FE) of 95 percent. Several KN95 respirators had a FE below 20 percent.

Manufacturers that are no longer approved by the FDA include:

• CTT Co. Ltd (87 percent FE)
• Daddybaby Co. Ltd (91.15 percent FE)
• Dongguan Xianda Medical Equipment Co., Ltd. (24.10 percent FE)
• Guangdong Fei Fan Mstar Technology LTD (61.60 percent FE)
• Guangdong Nuokang Medical Technology Co., Ltd. (24.22 percent FE)
• Huizhou Huinuo Technology Co., Ltd. (88.1 percent FE)
• Lanshan Shendun Technology Co., Ltd. (94.91 percent FE)

The complete list of banned KN95 masks with model numbers can be found here.

For each of the models listed, 10 respirators were submitted for testing and only particulate FE was tested. KN95 respirators are very similar to N95s, with only slight variations on specifications, according to a comparison guide published by 3M earlier this month. NIOSH also noted that most of the KN95 masks have an ear loop design, which may make an adequate fit more difficult. NIOSH-approved N95s typically have headbands.

When purchasing respirators from abroad, the CDC suggests following these guidelines to ensure informed decisions are being made. The CDC recommends that buyers evaluate the physical properties of the device, such as fit, quality of construction, and assessment of samples, if possible. Filtration efficiency should also be considered, as well as head harness design. Buyers should also evaluate the manufacturers and distributors of these devices and closely assess their contract terms. 

The FDA will continue to monitor the situation and will communicate the removal of any additional manufacturer eligibility via its Emergency Use Authorization (EUA) website. If any issues arise, the FDA encourages health care providers to report any suspicious actions here.

For more guidance on KN95 masks, visit the FDA’s EUA website to view or search for specific devices, or to check for updates. The full list of NIOSH’s test results can be found here—the organization regularly updates their testing. The CDC also published a webinar on purchasing respirators from overseas.

This article will be updated as necessary.