REFLEX NITRILE GLOVES N80B WITHOUT POWDER – gr. 3.0

The CE mark means European compliance and certifies that the product respects the regulations in force within the European Community that govern the production and placing in the product market.

Products used as Medical Devices pursuant to Reg EU 2017/745, EN 455 1, 2, 3 & 4. The EU Regulation 2017/745 on medical devices provides the requirements for the production of gloves to be used in healthcare (so also dental), as well as the obligations of labelling and evaluation of biological safety. The gloves considered Medical Devices ensure protection from cross contamination for both the patient and the user as they are considered an effective barrier to biological fluids and microorganisms.

Regulation EU 2016/425: repealed and replaced in April 2018 the previous Directive 89/686/EEC and identifies 3 classes of DPI on the basis of the definition of risk:
– CAT I: minor risks, self-certification;
– CAT II: intermediate level risks (not I and III), certified by accredited bodies;
– CAT III: very serious risks that can cause death or irreversible damage to health, certified by accredited bodies.

Only accredited entities are able to issue CE CAT II and CAT III certifications. Without the CE mark, the glove cannot be sold or used in the professional field.