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May 7, 2020: FDA Advises Certain Filtering Facepiece Respirators from China May Not Provide Appropriate Respiratory Protection

Respirators from China News – The U.S. Food and Drug Administration (FDA) has issued a letter to the following regarding concerns with certain filtering facepiece respirators (respirators) from China: Chinese companies producing the at issue respirators, U.S. Health Care Personnel, Hospital Purchasing Departments/Distributors, and other applicable stakeholders/consumers.

Respirators from China Information

On May 7, 2020, the FDA issued a letter regarding concerns over certain respirators from China. The outlined respirators may not provide consistent and adequate respiratory protection to health care personnel exposed to COVID-19 (coronavirus) based on additional filtration performance testing conducted by the National Institute for Occupational Safety and Health (NIOSH) and National Personal Protective Technology Laboratory (NPPTL) of the Centers for Disease Control and Prevention (CDC). Pursuant to the testing, the FDA has revised and reissued its April 3, 2020 Emergency Use Order (EUA).

Per the FDA, they have revised the following as part of their EUA eligibility criteria for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators manufactured in China:

[T]he criterion for authorization of respirators based on review of test reports from recognized independent test laboratories submitted to the FDA by the manufacturer or importer – and accordingly removed from Appendix A the respirators that had been authorized under that criterion, regardless of whether they passed or failed the NIOSH testing. The FDA is taking this public health action because a number of these respirators failed to demonstrate a minimum particulate filtration efficiency of 95 percent in testing conducted at NIOSH.

Respirators removed from Appendix A of the EUA and that did not meet their labeled performance standard are no longer eligible and no longer authorized to be sold or marketed in the U.S. as respirators. Instead, they may be re-labeled as face masks and authorized if certain criteria under the Face Mask umbrella EUA are met.

Non-NIOSH-approved respirators that continue to meet the other eligibility criteria in the reissued EUA remain authorized for use by the FDA during the COVID-19 pandemic.

The following products failed to demonstrate a minimum percent particulate filtration efficiency of 95% in NIOSH testing:

  • CTT Co. Ltd
  • Daddybaby Co. Ltd
  • Dongguan Xianda Medical Equipment Co., Ltd.
  • Guangdong Fei Fan Mstar Technology LTD
  • Guangdong Nuokang Medical Technology Co., Ltd.
  • Huizhou Huinuo Technology Co., Ltd.
  • Lanshan Shendun Technology Co

The FDA will continue to keep health care providers and the public apprised of any new or additional information as it becomes available.

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