Earlier this year, the outbreak of the epidemic led to a significant surge in the demand for medical supplies, and many people used some "informal" ways to export medical supplies.

In order to strengthen the quality control of medical supplies exports, in early April, the General Administration of Customs issued an announcement that epidemic prevention materials (masks, respirators, gloves, etc.) were included in the export legal inspection program.

Customs requires medical supplies must go through a procedure - customs declaration. If they are not declared truthfully, or if the products are found to be unqualified, the shipper will be subject to administrative penalties.

But the release of the announcement also brought new troubles - how to distinguish between medical / non-medical devices? The distinction of masks has caused a wave of public opinion, and the issue of distinguishing gloves has followed.

Medical gloves are classified as legal inspection of goods in the end how to identify? How exactly do you quickly and accurately distinguish between medical gloves and non-medical gloves?

Knock on the blackboard! Please look down!

Gloves can be divided into medical gloves and non-medical gloves according to their use. Medical gloves can be divided into medical surgical gloves and medical examination gloves according to the use scenario.

The distinction between medical/non-medical gloves is not difficult and can be made based on the appearance and packaging information, the applicable standards for the product, and government registration and control information.

Distinguish by appearance

Medical gloves are mainly made of natural rubber gloves, nitrile rubber gloves, polyethylene (PE) gloves and polyvinyl chloride (PVC) gloves. Non-medical gloves are made of a wider variety of materials, in addition to the above four, there are also cloth gloves, leather gloves, etc. General Administration of Customs Notice No. 53 of 2020 announced in the annex of the four medical gloves tax code 3926201100, 3926201900, 4015110000, 4015190000 items are plastic, rubber goods, if the gloves are not these two materials, basically can be judged as non-medical gloves.

Distinguished by packaging information

Observe whether the product packaging information with "medical" or English "surgical", "medical" and other words, whether the description of medical class use scenarios and Medical use, if there is relevant information, generally can be determined as medical gloves.

According to the test report or certificate provided by the manufacturer, the applicable standards can be distinguished from medical/non-medical gloves.

Export to the United States medical/non-medical gloves differentiation

Medical gloves are medical devices in the United States, managed by the U.S. Food and Drug Administration (FDA), and must be listed in the U.S. only after obtaining factory registration and medical device listing through 510(k) registration or other means recently announced by the FDA.

There is also a difference in the applicable standards for medical/non-medical gloves. If the glove has the FDA logo on the outer packaging or on the test report and certificate provided by the producer, or is labeled with the appropriate applicable standard, it can generally be determined to be a medical glove.

Tip Note: On December 19, 2016, the FDA issued a final rule banning powder gloves and decided to ban powdered gloves in medical activities, including powdered surgical gloves, examination gloves and surgical gloves used to lubricate absorbable powder. If an exported item is a powdered glove and is not marked with the FDA logo, the odds are that it will be determined to be a non-medical glove.

Export to EU medical/non-medical gloves differentiation

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

Medical gloves are medical devices in the EU and need to be CE marked in accordance with the EU Medical Device Regulation 2017/745/EU (MDR), which corresponds to EN 455-1/EN 455-2/ EN 455-3/ EN 455-4. Gloves sent to the EU with the above-mentioned contents on the outer packaging or test reports and certificates can generally be judged as medical gloves.

Non-medical gloves in the EU are governed by (EU) 2016/425 technical regulations, corresponding to the standards EN374, EN388, EN407, EN420, etc.

Export of medical gloves from other countries and regions, corresponding to some of the applicable standards are listed below, such as the glove outer packaging or the producer to provide test reports, certificates with such content, can generally be judged as medical gloves.