The Difference Between Medical Masks And Non-Medical Masks

Published:

2023-08-23


1. 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 scopes of application.

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

Distinguish by mask structure

Recognized by the filter valve. Masks with filter valves are generally not medical masks. For example, clause 4.3 of the Chinese standard for medical protective masks GB 19803-2010 clearly stipulates that “masks should not have an exhalation valve”, which can prevent droplets and microorganisms 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, thereby facilitating long-term work of the operator.

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 standards and the protection level. The information expressed by these businesses can be used as a distinguishing point. For example, if the product name contains words such as "medical" or "surgical" or "Medical" in English, it can generally be judged as a medical mask.

3. 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 outer packaging of the product 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 recently to obtain factory registration and 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 marketed in the United States.

Export to EU

EU medical/non-medical masks need to be affixed with the CE mark, but the applicable standards are different.

Medical masks are classified as Class I devices in the European Union. They are classified into Class I non-sterile and sterile. They need to be affixed with CE in accordance with EU Medical Device Directive 93/42/EEC (MDD) or EU Medical Device Regulation EU2017/745 (MDR) The mark, the corresponding standard is EN14683, and the masks exported to the European Union with the above content on the outer packaging or test reports or certificates can be judged as medical masks.

It should be noted that according to the sterile/non-sterile status 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 corresponding documents and test reports, you can complete the declaration of conformity by yourself. Sterile medical masks must also be CE certified by an authorized notification agency.

Non-medical masks exported to the EU are not medical devices, but they need to meet the requirements of the EU Personal Protective Equipment Regulation EU2016/425 (PPE). The authorized notified body will carry out CE certification and issue a certificate. 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 Chinese medical mask standards, GB 19083-2010, YY 0469-2011, YY/T 0969-2013, use Masks produced by these three standards can be judged as medical masks.