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Do Your Examination Gloves Give You All The Security You Expect?

10/04/20

Important regulatory changes: do your examination gloves provide you with all the safety you expect in your medical practices?

You use examination gloves in a healthcare facility, a medico-social facility, a doctor’s office or in your patients’ homes.

Now require gloves that comply with new European regulations – Personal Protective Equipment (PPE 2016-425 EU) and Medical Devices (DM 2017-745 EU).

For these products, compliance with the new regulations as well as compliance with new or amended technical standards, are now the best guarantee of safety during the care provided and when handling chemical or biological products in your daily working environments.

What changes:

  • It is a more stringent assessment of protection against microorganisms. Now the examination gloves must undergo bacteriophage tests to guarantee effectiveness against viruses; the packaging of the glove boxes will then include the mention “VIRUS” to justify conformity to the tests.
  • It is a better readability of information regarding protection against chemicals. Thus in the technical file and on the packaging if a glove is marketed with a claim for high protection against chemicals, it must now be PPE Category III. Depending on its level of protection, the glove will be Category III TYPE A, B or C. A being the best level of protection.
  • It is the labeling of compliance with the two regulations Medical Devices and Personal Protective Equipment. The packaging includes many new headings to certify and inform the user of compliance with the manufacturer’s claims.
  • For the gloves’ compliance with the PPE regulation, the notified body draws up an EC type examination certificate in the name of the manufacturer and / or the distributor on which the exact references marketed by the latter, as well as all the information in link with the level of protection against biological and / or chemical agents.
  • Finally, what is not expressly provided for by European regulations but which may be wise to check for caregivers handling anticancer molecules, these are the protection data provided by the manufacturers, when they exist, with regard to the American standard ASTM D6978 relating to protection requirements against cytostatic molecules.

The manufacturers of examination gloves must now ensure that the products placed on the market meet all these compliance criteria to protect your hands.

Didactic is committed to working with you to provide you with gloves that comply with the two new European regulations and guarantees all of these protection parameters for its entire range of Polysem Medical brand gloves.

For more information, contact us to receive the complete file

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