Views: 0 Author: Site Editor Publish Time: 2022-04-26 Origin: Site
Medical gloves must be exported to implement legal inspection, non-medical gloves for non-inspected goods, exports do not need to implement legal inspection. So let's understand how to quickly and accurately distinguish between medical and non-medical gloves.
Here is the content list:
Medical/non-medical gloves by application
Distinguish medical/non-medical gloves by appearance and packaging information
Use of commodity application criteria to distinguish medical/non-medical gloves
Use of government registration control information to distinguish medical / non-medical gloves
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 applicable scenarios.
Medical-surgical gloves: surgical operations such as various types of surgery, central catheter placement, total gastrointestinal parenteral nutrition solution preparation, etc.
Medical examination gloves: used when in direct or indirect contact with patients' blood, body fluids, secretions, excretions, and items contaminated by body fluids.
Non-medical gloves: For daily work (non-medical work) and life operations that require hand protection, such as industrial manufacturing, cleaning labor protection, experimental chemistry, or certain operations with hygiene requirements, such as food processing, etc.
By appearance: medical gloves are mainly made of natural rubber, nitrile, polyethylene (PE), and polyvinyl chloride (PVC). Non-medical gloves material variety, in addition to the above four, there are cloth gloves, leather gloves, etc. No. 53 announced in the annex of the four medical gloves tax numbers 3926201100, 3926201900, 4015110000, 4015190000 under all plastic, rubber material. If the gloves are not these two materials, basically can be determined as non-medical gloves
Distinguish by packaging information: observe whether the product packaging information with "medical" or English "surgical", "medical" and other words, whether the description medical scenarios and medical uses. If there is relevant information, it can generally be judged as medical gloves.
According to the commodity packaging or the producer to provide the test report, the applicable standards marked in the certificate can be distinguished from the gloves for medical / non-medical.
U.S. Standards: Medical gloves are medical devices in the U.S. and are 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 as recently announced by the FDA. If the glove packaging or manufacturer provides test reports and certificates with FDA-related information or is marked with the appropriate applicable standards, it can generally be determined to be a medical glove.
EU standards: EU medical/non-medical gloves are required to be CE marked, but the applicable standards are different. Medical gloves are medical devices in the EU and require CE marking by the EU Medical Device Directive 93/42/EEC (MDD) or the EU Medical Device Regulation 2017/745/(MDR). The corresponding standard is EN 455-1/EN 455-2/ EN 455-3/ EN 455-4. Gloves exported to the EU with the above-mentioned contents on the outer packaging or test report or certificate 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 EN 374, EN 388, EN 407, EN 420, etc.
Since medical gloves are registered or controlled as medical devices in most countries or regions, consumers can further distinguish them through relevant registration and control information.
Medical gloves are Class II medical devices in China and are registered and managed by the provincial drug regulatory authorities, which can be accessed through the medical device access number.