The typical N95 mask is supposed to block out 95% of particles from the air, as per the name. Those particles can include infectious bacteria and viral particles. A KN95 is equivalent to an N95 mask, but is designed to meet Chinese mask standards, which are slightly different to American ones.
For front-line healthcare workers, wearing a properly fitted mask could be lifesaving, if the masks are up to code. Many of the masks NIOSH tested were not.
NIOSH found that one KN95 mask, which was packaged with an unauthorized FDA logo, only filtered out 35% of particles. Another filtered only 50%.
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Many of the imported masks used ear loops instead of the tight-fitting NIOSH-approved headbands, despite the fact that N95 masks only work when they fit tightly around the nose and mouth, creating a seal that virus-laced droplets cannot penetrate. KN95 masks use ear loops, which fit Chinese standards, but not American, because they can create a looser seal around the face.
According to the Wall Street Journal, hundreds of thousands of imported masks bound for children's hospitals, care homes, and ICUs have been seized by authorities at a New York airport. Testing showed that these masks, which had packaging that stated they were approved by NIOSH, failed to meet NIOSH certifications, filtering between 83% and 91% of particles.
George Gianforcaro, owner of Newark-based Indutex USA, who distributed the masks, says he does not know where the masks are and lost millions over them.
These imported masks entered America because of a FDA Emergency Use Authorization
This influx of N95 imports entered the country because of a Emergency Use Authorization the FDA issued in an effort to combat the US' terrifying mask shortage.
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The authorization allowed masks certified in countries like China, Japan and Brazil, to be sold in the United States.
With federal approval, many of these masks were hurriedly imported from China and other countries to help American healthcare workers stay safe while treating COVID-19 patients.
Lynn Risacher, a nurse at Lawrence General Hospital in Massachusetts, told the Wall Street Journal that four days after she wore one of these imported masks with ear loops, she began to feel the COVID-19 symptoms of shortness of breath and coughing. Many of her colleagues had also worn the masks.
"We weren't protected," she said.
NIOSH tested 10 samples of each mask for its test of filtration efficiency.
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Manufacturers have sounded the alarm about counterfeit masks
3M, a leading mask manufacturer, wrote a letter to Attorney General William Barr, alerting him to the growing number of counterfeit 3M products being sold to Americans. Honeywell and Prestige Ameritech manufacturers also issued fraud warnings.
"Counterfeit respirators are products that are falsely marketed and sold as being NIOSH-approved and may not be capable of providing appropriate respiratory protection to workers," the CDC wrote in a guide on its website.
"When NIOSH becomes aware of counterfeit respirators or those misrepresenting NIOSH approval on the market, we will post them here to alert users, purchasers, and manufacturers."
In the guide, the CDC posted photos of masks from G & F Products, Maskin, and Medicos, telling consumers that they are not federally approved.
Signs of a counterfeit N95 include the presence of decorative fabric or add-ons like sequins, claims that the mask has been specially approved for children, ear loops instead of a headband, no markings on the respirator and no approval numbers on the respirator or the headband.
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