Canadian-approved N95 mask targeted by Chinese counterfeiters

A Chinese-made mask approved by Health Canada is the subject of a counterfeit warning issued by the Centers for Disease Control and Prevention in the U.S.

The Associated Press has reported that counterfeit masks, intended to mimic medical-grade N95 masks made by the Shanghai Dasheng company and approved for use in Canada, already have been distributed to front-line medical staff at some U.S. hospitals.

And a separate Chinese mask maker also licensed by Health Canada has seen its approval pulled by the Food and Drug Administration in the United States.

The Guangdong Golden Leaves Technology Development Co. Ltd. was one of 65 Chinese manufacturers whose authorization to sell in the U.S. was withdrawn following tests by the Centers for Disease Control (CDC).

The manufacturer remains approved in Canada, but its product has not been distributed to health care workers here, a spokesperson for Public Services and Procurement Canada told CBC News.

Both cases illustrate the difficulties faced by governments in trying to procure reliable masks when a flood of fake, shoddy and deceptively-labelled products is pouring out of China.

Fake numbers proliferating

All masks approved for use in U.S. hospitals must have a Testing and Certification (TC) number issued by the National Institute for Occupational Safety and Health. The CDC has warned that the TC number issued to the Shanghai Dasheng Co. for its masks — TC 84A-4329 — has been misappropriated by other Chinese makers seeking to sell substandard products in the U.S. market.

U.S. government agencies like the National Park Service have been warning their workers to watch out for the fake masks.

Health Canada approved Shanghai Dasheng's DTC3X N95 masks by interim order on April 27. That interim order process has been used during the pandemic to fast-track approval of medical devices for use in Canada.

West Virginia distributed 50,000 fake DTC3X masks to first responders — and kept them in use after the CDC warned the state they might be counterfeit, and after the real Shanghai Dasheng Co. warned that its products were being faked.

CBC News has asked Health Canada and Public Services and Procurement Canada about the masks, but has not yet received an answer.

Testing reveals quality problems

Canada was badly burned once already when it bought millions of defective masks from a Montreal-based supplier that uses Chinese manufacturers.

The U.S. government had to withdraw dozens of approvals for Chinese manufacturers of medical masks last week after tests showed that many did not meet minimum standards for protecting medical workers.

One of those mask manufacturers also had received approval in Canada.

Products made by Guangdong Golden Leaves Technology Development Co. Ltd. had been cleared for use in the U.S. under an "Emergency Use Authorization" (EUA) issued by the Food and Drug Administration (FDA) on April 3.

The same maker was approved by Health Canada on May 5.

But on May 9, the FDA withdrew the company's U.S. licence. That decision followed tests by the CDC that showed many of the Chinese masks permitted under the EUA fell far below the filtration standards guaranteed by their producers.

CDC has not published a test of the Guangdong Golden Leaves mask, but appears to have de-listed it as a precaution after other masks approved by the same Emergency Use Authorization tested poorly.

11 tests, seven fails

While Canada tests masks before approving them for use, the U.S. government chose to grant approvals before testing.

Of 11 masks tested by the CDC for which results were published, only four met specifications. The stop-use order relates not only to the seven that failed, but also to dozens of others that have yet to be tested, including the Guangdong Golden Leaves mask.

Just 14 of the 80 Chinese mask makers approved in the original order remain cleared for use in the United States today.

"While the FDA 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," the agency said in a statement.

Mixed quality

The test results just for masks shipped from China's Guangdong province show vast differences in quality.

Some of the Chinese manufacturers shipped masks that performed superbly in tests.

N95 and KN95 masks are supposed to be able to filter at least 95 per cent of all particles measuring 0.3 microns in diameter. All 10 samples of the KN95 produced by Guangdong Energy Fortress Pharmaceutical Co. passed that test, and four of them performed at 100 per cent filtration.

A mask produced by Guangdong Medical Technology Co. produced equally consistent results.

But none of the 10 samples of the mask produced by Guangdong Qian Jing Testing Co. filtered more than 76 per cent of particles — a dismal rating.

And masks produced by Guangdong Nuokong Medical Technology Co. appeared to be from two very different production runs. Of the 10 samples tested, five produced good filtration rates of between 98 and 99 per cent, but five gave only 24 to 26 per cent protection.

A scramble to sell masks

The pandemic has inspired many manufacturers in China to jump into the personal protective equipment (PPE) business to take advantage of the scramble among countries around the world to procure supplies.

While many of the companies approved by the FDA in the April 4 emergency order were traditional medical supply firms with a history of making such products, the names of some approved companies reveal an origin that has little to do with health or medicine: DongGuan HuaGang Communication Technology Co., Fujian Pageone Garment Co, Ltd., Guangzhou Sunjoy Auto Supplies Co., Yiwu Henghao Household Products Co., Yiwu Yifan Knitting Co., the Zhejiang Shengtai Baby Products Co.

None of those non-medical companies appear to have survived the FDA's cull of manufacturers.

Nine of the Chinese mask manufacturers that retained their approvals in the U.S. also have been approved in Canada, but none of the masks that failed CDC tests appear on the Canadian approved list.

However, on Monday, Health Canada issued a recall of KN95 respirators manufactured by dozens of Chinese companies following CDC tests that found the masks "failed to meet 95 per cent filtration specifications."

A recall bulletin was sent to companies across Canada authorized to import or distribute supplies for use in hospitals or other health-care institutions, instructing them to "stop-sale" of the masks and relabel them for use in non-healthcare settings where 95 per cent filtration isn't necessary.

Ottawa said the recall action did "not implicate KN95 respirators purchased by the Government of Canada and tested by the Public Health Agency of Canada (PHAC)."

Shoddy materials go worldwide

Concerns over the quality of PPE and test kits have arisen outside North America as well. Several European countries have had sometimes acrimonious disputes with China over the quality and reliability of shipments.

Fast-track approval processes were adopted in many countries to speed up the delivery of supplies, and sometimes that has opened the door to substandard equipment.

Both the U.S. and the United Kingdom have reported serious problems with test kits that were granted expedited approval.

Canada also has bought defective test kits from China.

In some cases, disputes over shoddy Chinese shipments to Europe have led to diplomatic incidents, with Chinese embassies vigorously defending the quality of shipments condemned by local health authorities.