How to distinguish between medical gloves and non-medical gloves?
September 16,2021
With the continuous development of epidemic, distinguishing the medical and non-medical masks and gloves can protect ourselves better. This blog will give you some reference.
Distinguish by purpose
Gloves can be divided into medical gloves and non-medical gloves according to their purpose. Medical gloves can be divided into medical surgical gloves and medical examination gloves according to applicable scenarios.
➊ Medical surgical gloves
Surgical operations such as various operations, central catheter placement, and preparation of total parenteral nutrition solutions.
➋ Medical examination gloves
It is used when directly or indirectly contacting the patient's blood, body fluids, secretions, excreta and items that are obviously contaminated by body fluids.
➌ Non-medical gloves
Daily work (non-medical work) and operations that require the protection of the opponent in life, such as industrial manufacturing, cleaning labor insurance, experimental chemistry, or certain operations that have hygienic requirements, such as food processing.
Distinguish by appearance and packaging information
Distinguish by appearance
Medical gloves are divided into natural rubber gloves, nitrile rubber gloves, polyethylene (PE) gloves and polyvinyl chloride (PVC) gloves. If the gloves are not made of these four materials, they can basically be judged as non-medical gloves. There are many types of non-medical gloves. In addition to the above four, there are cloth gloves and leather gloves.
Distinguish by packaging information
Observe whether the product packaging information contains words such as "医用" or "surgical" and "medical", and whether it describes medical application scenarios and medical uses. If relevant information is available, it can generally be judged as medical gloves.
Distinguish by product applicable standards
Gloves can be distinguished as medical/non-medical according to the applicable standards marked in the product packaging or the test report and certificate provided by the manufacturer.
✊American standards
Medical gloves are medical devices in the United States and are regulated by the U.S. Food and Drug Administration (FDA). They must go through 510(k) registration or other channels recently announced by the FDA to obtain factory registration and medical device listing before they can be marketed in the United States.
If the glove outer packaging or the manufacturer provides the test report and certificate with FDA-related information, or the corresponding applicable standard is marked, it can generally be judged as a medical glove.
In 2016, the US Food and Drug Administration 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 it is a powder glove without FDA-related information, it can be judged as a non-medical glove with a high probability.
✊Relevant EU standards
EU medical/non-medical gloves are required to be affixed with the CE mark, but the applicable standards are different.
Medical gloves are medical devices in the EU and need to be affixed with the CE mark in accordance with 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 European Union with the above contents on the outer packaging or test report or certificate can generally be judged as medical gloves.
Non-medical gloves are governed by (EU) 2016/425 technical regulations in the European Union, and the corresponding standards are EN 374, EN 388, EN 407, EN 420, etc.
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