Industry News

Applicable standards distinguish medical/non-medical masks


Different standards and certification requirements apply to medical masks in different countries/regions. Enterprises and individuals can be distinguished according to the country/region where the product is imported and according to the applicable standards of the product. The applicable standards and certification information of the product can be obtained from the product packaging or the manufacturer’s Obtain test report or certificate.


Export to the US

Medical masks are medical devices in the United States, and are subject to the "Standard Specification for the Performance of Medical Mask Materials" (ASTM F2100). They are managed by the US Food and Drug Administration (FDA) and must be registered by the 501K or other channels recently announced by the FDA to obtain factory registration and Medical devices are listed in the United States after being listed. Therefore, the mask packaging exported to the United States or the test report or certificate that contains the above content can be judged as a medical mask.

Non-medical masks exported to the United States are outside the scope of Announcement No. 5 of 2020, but companies should note that products need to be registered with the NIOSH before they can be listed in the United States.


Export to other countries and regions

Mask products exported to other countries and regions can be judged by referring to the Chinese standard test certificate and registration information provided by them. There are three Chinese medical mask standards, GB 19083-2010, YY 0469-2011, YY/T 0969-2013, use The masks produced by these three standards can be judged as medical masks.