Masks can be divided into two categories: medical and non‑medical. As the names suggest, medical masks are primarily used for healthcare protection and come in three types: medical protective, medical surgical, and disposable medical masks. Non‑medical masks, also known as personal protective masks, can be further classified according to their intended use into particulate‑filtering masks and everyday protective masks. Masks designed for different purposes have varying technical requirements and application scopes.

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

Classified by mask structure

This is addressed by the filter valve. Masks equipped with a filter valve are generally not medical-grade masks. For example, Clause 4.3 of the Chinese standard for medical protective masks, GB 19803-2010, explicitly stipulates that “masks shall not be fitted with an exhalation valve,” as such valves can allow droplets and microorganisms to be expelled, thereby posing a risk to others. By contrast, civilian‑grade face masks may be permitted to have exhalation valves. Exhalation valves reduce exhalation resistance, which is advantageous for users who must work for extended periods.

Distinguish by the information on the outer packaging.

The minimum packaging of mask products sold through official channels must include information such as the product name, applicable standards, and protection level. The information provided by these sellers can serve as a distinguishing factor. For example, if the product name contains the English terms “Medical,” “Surgical,” or “Medical,” it is generally considered a medical-grade mask.

3. Classification of applicable standards: medical/non-medical masks

Medical masks in different countries and regions are subject to varying standards and certification requirements. Businesses and individuals can differentiate products based on the country of import and the applicable product standards. Information on the relevant product standards and certifications can be obtained from the product packaging or the manufacturer, along with test reports or certificates.
Export to the United States

Medical masks are medical devices in the United States, subject to the “Standard Specification for Performance of Materials Used in Medical Masks” (ASTM F2100) and regulated by the U.S. Food and Drug Administration (FDA). They must be registered through the 501(k) pathway or other channels recently announced by the FDA to obtain facility registration, and such medical devices may only be marketed in the United States after approval. Accordingly, mask packaging intended for export to the U.S., along with test reports or certifications containing the aforementioned information, may be regarded as evidence that the product qualifies as a medical mask.

Non‑medical masks exported to the United States are not covered by Announcement No. 5 of 2020; however, companies should note that such products must be registered with NIOSH before they can be marketed in the U.S.

Exported to the European Union

EU medical and non-medical masks must bear the CE marking, but the applicable standards differ.

Medical masks are classified as Class I devices under EU regulations, and are available in both non-sterile and sterile versions. They must bear the CE marking in accordance with either the EU Medical Device Directive 93/42/EEC (MDD) or the EU Medical Device Regulation (MDR) EU 2017/745. The applicable standard is EN 14683, and a test report or certificate must be provided on the mask packaging or for export to the EU.

Including the aforementioned components, it can be regarded as a medical mask.

It should be noted that, depending on whether a mask is sterile or non‑sterile, the European Union applies different conformity‑assessment procedures. For non‑sterile medical masks, companies are only required to issue a self‑declaration of CE conformity and are not obliged to obtain certification from a designated body; once the relevant documentation and test reports are in place, they may complete the declaration of conformity themselves. Sterile medical masks, however, must undergo CE certification by an authorized notified body.

Non‑medical masks exported to the European Union are not classified as medical devices, but they must comply with the requirements of the EU Personal Protective Equipment Regulation (EU) 2016/425 (PPE). CE certification is issued by a notified body. The relevant standard is EN 149.

Exported to other countries and regions

Mask products exported to other countries and regions can be assessed based on the Chinese standard test certificates and registration information provided by those jurisdictions. China has three standards for medical masks: GB 19083-2010, YY 0469-2011, and YY/T 0969-2013. Masks manufactured in accordance with any of these three standards may be classified as medical masks.