How To Identify Medical Protective Masks

Recently, there has been a continuous outbreak of new pneumonia in foreign countries, and the demand for masks and other epidemic prevention materials has increased greatly. Due to the different standards of various countries, cases in which non-medical masks exported by China are misused for medical treatment have occurred from time to time. On March 31, the Ministry of Commerce, together with the General Administration of Customs and the Food and Drug Administration, issued the Announcement on the Orderly Development of Export of Medical Materials (No. 5 of 2020), requiring that export of medical masks and other 5 types of products must be obtained Qualifications meet the quality standards of the importing country (region).
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So, how to distinguish medical and non-medical masks quickly and accurately? Let’s talk together.
1 Basic classification and subdivision of masks
Masks can be divided into two categories: medical / 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 protective Particulate matter and daily protection. Masks for different purposes have different technical requirements and different scopes of application.
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2 Use appearance and packaging information to distinguish medical / non-medical masks
Distinguish by mask structure
Resolved 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 states that “masks should not have an exhalation valve”. This can prevent droplets, microorganisms, etc. from exhaling through the exhalation valve, thereby harming others. Civil masks are allowed to have an exhalation valve. The exhalation valve can reduce the exhalation resistance, which is beneficial for the operator to work for a long time.

Identify by the information on the outer packaging
The minimum unit package of mask products sold through formal channels should have information such as the name of the product, the standards implemented 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 “Medical” or “surgical” and “Medical” in English, it can generally be regarded as a medical mask.
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3 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 in which the product is imported and according to the applicable standards of the product. Obtain test report or certificate.Export to the United States
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 through the 501K or other channels recently announced by the FDA to obtain factory registration 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.
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Export to the EU
The European Union medical / non-medical masks are required to bear the CE mark, but the applicable standards are different.
Medical masks belong to Class I devices in the European Union, which are divided into Class I non-sterile and sterile. They need to be affixed with CE in accordance with the EU Medical Device Directive 93/42 / EEC (MDD) or the EU Medical Device Regulations EU2017 / 745 (MDR) The mark, the corresponding standard is EN14683, and the mask packaging or test report or certificate exported to the EU contains the above-mentioned contents, and it can be judged as a medical mask.
It should be noted that according to the aseptic / non-sterile state of the mask, the EU adopts different conformity assessment methods. Non-sterile medical mask companies only need to make a CE self-conformity declaration, and do not need to pass the certification of the notified body. After preparing the relevant documents and test reports, you can complete the declaration of conformity yourself. Sterile medical masks must also be CE certified by an authorized notified body.
Non-medical masks exported to the EU are not medical devices, but they must meet the requirements of the EU Personal Protective Equipment Regulations EU2016 / 425 (PPE). CE certification and certificates are issued by authorized notified bodies. The corresponding standard is EN149.
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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.
No matter how good you feel about the manufacturers, it is always a good idea to do inspections and due diligence for all your suppliers.
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