Basic classification of gloves
Medical making machine factory introduces: gloves can be divided into Medical gloves and non-medical gloves according to their USES.Medical gloves can be divided into surgical gloves and medical inspection gloves according to the applicable scene.
Surgical gloves: surgical operations such as various operations, central catheter catheterization, total parenteral nutrition fluid preparation and other use.
(2) medical inspection gloves: for direct or indirect contact with the patient’s blood, body fluids, secretions, excreta and articles obviously contaminated by body fluids.
(3) non-medical gloves: in daily work (non-medical work) and life, some operations need hand protection, such as industrial manufacturing, cleaning labor protection, experimental chemistry, or some operations have health requirements, such as food processing.
two
Distinguish by appearance and packaging information
A: by appearance
The materials of medical gloves mainly include natural rubber gloves, nitrile rubber gloves, polyethylene (PE) gloves and polyvinyl chloride (PVC) gloves.There are many kinds of non-medical gloves, including cloth gloves and leather gloves.The four kinds of medical gloves with tax Numbers 3926201100, 3926201900, 4015110000 and 4015190,000 announced in the attachment of no. 53 announcement are made of plastic and rubber materials.If the glove is not made of these two materials, it can be considered as a non-medical glove.
B: by packaging information
Observe whether the words “surgical” or “medical” in English are included on the package information, and whether the medical application scenarios and medical USES are described.If there is relevant information, it can be judged as medical gloves.
three
According to the applicable standard of goods
Gloves can be classified as medical/non-medical according to the applicable standards indicated in the test report and certificate provided by the commodity packaging or manufacturer
A: to the United States
Medical gloves belong to medical devices in the United States, which are regulated by the United States food and drug administration (FDA). They can only be marketed in the United States after obtaining the factory registration and medical device listing through 510 (k) registration or other means recently announced by the FDA.
If the outer packaging of gloves or the manufacturer provides the testing report and certificate with FDA related information, or marks the applicable standards, the gloves can generally be judged as medical gloves.
Pay attention to
In 2016, the U.S. food and drug administration issued a final rule banning powder gloves, deciding to ban powder gloves from medical activities, including powder surgical gloves, inspection gloves, and surgical gloves used to lubricate absorbable powder.If powder gloves are not marked with fda-related information, they can be judged as non-medical gloves with high probability.
B: to the European union
European union medical/non-medical gloves are required to be covered with the CE mark, but the applicable standards are different.
Medical gloves belong to medical devices in the eu, and the CE mark shall be affixed in accordance with the eu medical device regulations 2017/745 / (MDR).The corresponding standard is EN 455-1 / en455-2 / en455-3 / en455-4. Gloves imported to the eu with the above contents on the outer packaging, test report and certificate are generally judged to be medical gloves.Non-medical gloves are governed by the European union (EU) technical regulations 2016/425. The corresponding standards are EN374, EN388, EN407, EN420, etc.
four
Use government registration to control information differentiation
Since medical gloves are registered or controlled according to medical devices in most countries or regions, they can be further distinguished by relevant registration control information.
A: China
Medical gloves belong to class ii medical devices in China, which are registered and managed by the provincial drug regulatory department at the first level, and can be inquired through the access number of medical devices.
B: The U.S.
Gloves that have been approved by the FDA of the United States can be checked through their registration number on their official website.
C: the European union
The export of eu medical gloves can be inquired about through an authorized notified body. The European union has published a series of bodies authorized by the European union ‘s unified supervision and certification authority, also known as the NB agency, and granted each institution a unique four-digit code known as the announcement number.The application and issue of CE certificate shall be issued by the notice number body authorized by the corresponding regulations and instructions.
