In the global rush to procure high quality medical-grade face masks, literally millions have been found to be substandard and had to be rejected.
Now comes word of even more concerns as counterfeiters from China have become involved.
the KN-95 standard masks that had been approved by Health Canada are now the subject of a warning by the U.S. Centres for Disease Control (CDC). The masks by the Shanghai Desheng company, while another mask approved by Health Canada has had U.S approval pulled by the Food and Drug Administration there.
Health Canada has recalled KN95 masks produced by dozens of Chinese manufacturers after testing found them to ‘pose a health and safety risk to end users.’ (Maggie MacPherson/CBC)
N-95 masks are considered standard for medical use as the filter out 95 per cent of airborne particles down to 0,3 microns.
As it turns out, the real Shanghai Desheng company has warned that its DTC3X N95 masks were being faked.
The Guangdong Golden Leaves Technology Development Co. Ltd. masks still have Canadian approval but have not been distributed to health care workers here.
U.S approval for such masks comes from the National Institute for Occupational Safety and Health (NIOSH) which assigns a ‘testing and certification’ (TC) number.
In the rush to acquire personal protective equipment, many imported masks had approval fast tracked, while subsequent testing shows a great variation in quality. Several Chinese suppliers to both the Canada and U.S have now had approval revoked.
However, it seems that masks bearing actual approved NIOSH TC numbers are making their way to the market. Even NIOSH approval letters are being faked.
ABOVE and BELOW: These are examples of counterfeit respirators using Shanghai Dasheng Health Products Manufacture Co. Ltd’s (SDH) NIOSH approval numbers without their permission. These models include, but may not be limited to, models DTC3X (marked as TC-84A-4329), DTC3W (marked as TC-84A-4335), DTC3B (marked as TC-84A-4336), DTC3Z (marked as TC-84A-8150), and Raxwell RX9501P. Note that any SDH respirators with ear loops are NOT NIOSH approved. (U.S. Centers for Disease Control)
There is great concern that medical staff and others who think they are protected, may in fact be exposed to greater risk from substandard counterfeit products.
The problems do not concern only masks, but also substandard COVID-19 test kits purchased by many countries, along with fake mislabelled drugs.
Quoted by the Associated Press, Steve Francis assistant director of the U.S Homeland Security Investigations said of the counterfeiting of masks, gloves, protective gowns and more, “It’s just unprecedented. These are really bad times for people who are out there trying to do the right thing and be helpful, and they end up being exploited.”
additional information – sources
- CBC: E.Dyer: May 14/20: Canadian-approved N95 mask targeted by Chinese counterfeiters
- CBC: G.Leo: Mqy 13/20 Health Canada issues recall of some N95 masks made in China
- U.S Centres for Disease Control: May 13/20: Counterfeit respirators-misrepresentation of NIOSH approval
- Associated Press (via SCMP): May 13 Millions of counterfeit masks reaching frontline health workers
- CBC: J.Bronskill: May 8/20: Federal government rejects 8 million masks
- Politico: A.Blatchford: Apr 23/20: One million respirators acquired from China unfit
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