Masks can be divided into two categories: medical/non-medical. As the name suggests, medical masks are mainly used for medical protection and can be divided into three types: medical protection, medical surgery and disposable medical treatment. Non-medical masks are also called personal protective masks, which can be subdivided into anti-accumulation according to their application. Particles and daily protection. Masks for different purposes have different technical requirements and different application ranges

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

Distinguish by mask structure

Solved by the filter valve. Masks with filter valves are usually 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 liquid droplets and microorganisms can be exhaled through the exhalation valve, thereby harming others. Allow civilian masks with exhalation valves. The exhalation valve can reduce the exhalation resistance, which is beneficial for the operator to work for a long time.

Differentiate by the information on the outer packaging

The minimum packaging of mask products sold through formal channels should include information such as product name, implementation standards and protection levels. The information expressed by these merchants can be used as a point of distinction. For example, if the product name contains English "Medical" or "Surgical" and "Medical", it can usually be regarded as a medical mask.

3. Applicable standards distinguish medical/non-medical masks

Different standards and certification requirements apply to medical masks in different countries/regions. Companies and individuals can be distinguished based on the country/region where the product is imported and the applicable standards of the product. Applicable product standards and certification information can be obtained from the product packaging or the manufacturer. Obtain a test report or certificate.

Export to the U.S.

Medical masks are medical equipment in the United States, subject to the "Standard Specification for Material Performance of Medical Masks" (ASTM F2100) and are regulated by the US Food and Drug Administration (FDA). They must be registered through 501K or other channels recently announced by the FDA to obtain factory registration, and medical devices can only be marketed in the United States after they are marketed. Therefore, mask packages exported to the United States or test reports or certificates with the above content can be regarded as medical masks.

Non-medical masks exported to the United States are not within the scope of Announcement No. 5 of 2020, but companies should note that the products must be registered on NIOSH before they can be listed in the United States.

Export to EU

EU medical/non-medical masks must carry the CE mark, but the applicable standards are different.

Medical masks belong to the European Union's Class I equipment, which is divided into non-sterile and sterile Class I. A trademark must be affixed to the CE according to the EU Medical Device Directive 93/42/EEC (MDD) or EU Medical Device Regulation EU2017/745 (MDR), the corresponding standard is EN14683, and the mask packaging or the test report or certificate for export to the EU book

With the above content, it can be considered as a medical mask.

It should be noted that the EU adopts different conformity assessment methods according to the sterile/non-sterile status of the mask. Non-sterile medical mask companies only need to make a CE self-conformity declaration, and do not need to pass the certification of a designated agency. After preparing the relevant documents and test reports, you can complete the declaration of conformity by yourself. Sterile medical masks must also be CE certified by an authorized certification body.

Non-medical masks exported to the EU are not medical equipment, but they must meet the requirements of the EU Personal Protective Equipment Regulation EU2016/425 (PPE). CE certification and certification are issued by authorized certification bodies. The corresponding standard is EN149.

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 medical mask standards in China, namely GB 19083-2010, YY 0469-2011, and YY/T 0969-2013. The masks produced by these three standards can be judged as medical masks.