Guangdong Nuokang Medical Technology whose masks were recalled by the FDA
The U.S. Food and Drug Administration announced that only 14 mask manufacturers in China are licensed to produce N95-style masks for use in the U.S. Previously, around 80 manufacturers based in China could manufacture and export the masks to the United States.
Testing by the National Institute for Occupational Safety and Health (NIOSH) under the Centers for Disease Control and Prevention found that many of the masks did not meet the filtration standard—that is, they should filter out 95 percent of particles that are 0.3 microns or larger, according to the FDA.
Certain masks from China “may not provide consistent and adequate respiratory protection to health care personnel exposed to COVID-19,” the FDA said in a Thursday letter to healthcare providers.
Several European countries, have recalled or sent back faulty masks, test kits, and protective suits exported from China among which The Netherlands, who recently recalled 600.000 masks, Turkey and Spain.
In their letter the FDA is also listing some exporters who failed the tests: “Among products removed from Appendix A to date, the following failed to demonstrate a minimum percent particulate filtration efficiency of 95 percent in testing conducted by NIOSH:
- 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 believes respirators that no longer appear in Appendix A may not be reliably decontaminated in any decontamination system authorized for use during the COVID-19 pandemic.
An N95 mask or N95 respirator is a particulate-filtering facepiece respirator that meets the U.S. National Institute for Occupational Safety and Health (NIOSH) N95 classification of air filtration, meaning that it filters at least 95% of airborne particles.
N95 respirators are considered functionally equivalent to certain respirators regulated under non-U.S. jurisdictions, such as FFP2 respirators of the European Union and KN95 respirators of China. However, slightly different criteria are used to certify their performance, such as the filter efficiency, test agent and flow rate, and permissible pressure drop.
The N95 mask requires a fine mesh of synthetic polymer fibers, also known as nonwoven polypropylene fabric, which is produced through a process called melt blowing that forms the inner filtration layer that filters out hazardous particles.