Imported N95-Style Masks May Fail to Protect Healthcare Workers from Infectious Respiratory Diseases

January 28, 2021 | Evaluations & Guidance

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Imported N95-style masks that lack NIOSH certification may not protect the wearer as well as certified models do.

N95 masks—more accurately referred to as N95 filtering facepiece respirators (FFRs)—are certified by the U.S. National Institute for Occupational Safety and Health (NIOSH) as being able to block at least 95% of airborne particles under specified test conditions. During the COVID-19 pandemic, N95 respirators have been in high demand, as personnel require reliable respiratory protection from the SARS-CoV-2 virus. Unfortunately, the respirators have also been in short supply, which has prompted many healthcare organizations to seek alternative products.

KN95 respirators imported from China are one such alternative. These products are marketed as meeting a Chinese respirator standard with requirements that are closely aligned with the U.S. NIOSH standard for N95 respirators, but the products have not been certified to meet the NIOSH standard. In fact, ECRI laboratory testing conducted through December 2020 shows that 62% of the...

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