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How to Distinguish Non-Medical and Medical Masks?

Dec. 15, 2020

Recently, the outbreak of new crown pneumonia in foreign countries has continued, and the demand for anti-epidemic materials such as masks has greatly increased. Due to different national standards, my country's export of non-medical masks for medical purposes occasionally occurs. So, how to distinguish medical and non-medical masks quickly and accurately? Please find out with the medical mask supplier.

Basic classification and subdivision of masks

Masks can be divided into two categories: medical and non-medical. As the name suggests, medical masks are mainly used for medical protection, which can be subdivided into three types: medical protection, medical surgery, and disposable medical; non-medical masks are also called personal protective masks, which can be subdivided into protection according to their application scenarios. Both particulate matter and daily protection. Masks for different purposes have different technical requirements and different scope of application. 

Use appearance and packaging information to distinguish medical/non-medical masks

Medical Mask

Distinguish by mask structure

Recognized by the filter valve. Masks with filter valves are generally not medical masks. For example, Article 4.3 of the Chinese Medical Protective Mask Standard GB 19803-2010 clearly stipulates that “masks should not have an exhalation valve”, so that droplets, microorganisms, etc. can be prevented from exhaling through the exhalation valve, thereby harming others. Civil masks are allowed to have an exhalation valve, and the exhalation resistance can be reduced through the exhalation valve, which is beneficial for operators to work for a long time.

Distinguish by the information on the outer packaging

The smallest unit packaging of mask products sold through formal channels should have information such as the name of the product, the implemented standard and the level of protection. The information expressed by these businesses can be used as a distinguishing point. For example, if the product name contains the words "medical" or "surgical" or "Medical" in English, it can generally be judged as a medical mask.

Applicable standards distinguish medical/non-medical masks

Medical masks are subject to different standards and certification requirements in different countries/regions. Enterprises and individuals can distinguish according to the country/region where the product is imported and the applicable standards of the product. The applicable standards and certification information of the product can be provided from the product packaging or the manufacturer. Obtain the test report or certificate.

Export to the U.S.

Medical masks are medical devices in the United States. They are subject to the "Medical Mask Material Performance Standard Specification" (ASTM F2100) and are managed by the U.S. Food and Drug Administration (FDA). They must pass 501K registration or other channels announced by the FDA to obtain factory registration Medical devices can only be listed in the United States after they are listed. Therefore, masks exported to the United States on the outer packaging or test reports or certificates with the above content can be judged as medical masks.

The export of non-medical masks to the United States does not fall within the scope of Announcement No. 5 of 2020, but companies should note that products must be registered with NIOSH before they can be listed in the United States.

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