The CE marking (European Conformity marking) attests that the product meets the European Union rules and requirements for manufacturing and commercial marketing.
Products usable as Medical Devices according to Reg EU 2017/745, EN 455 1, 2, 3 & 4 norms. The Reg EU 2017/745 on medical devices provides the requirements for the production of gloves to be used in health (and therefore also dental), as well as the obligations of labeling and assessment of biological safety. The gloves considered Medical Devices provide protection from cross-contamination both for the patient and the user as they are considered an effective barrier to biological fluids and microorganisms.
In April 2018 the New PPE Regulation EU 2016/425 has amended and replaced the previous PPE Directive 89/686/EEC. The new PPE regulation now specifies three classes based on risk definitions:
– CAT I: minimal risk, self-certified;
– CAT II: intermediate risks (other than those listed in Categories I and III), certified by approved body;
– CAT III: very serious risks, which may cause death or irreversible damage to health; certified by approved body.
Only the approved bodies may issue a CE mark for PPE CAT II and CAT III. Without a proper CE mark the gloves may not be sold or used.
The gloves for alimentary use are not only a fundamental hygiene measure, it is also an FCM – Food Contact Material (Regulation EC 1935/2004 – Italian Ministerial Decree 21.03.1973, EU Reg. 10/2011).
What are FCMs? “Any material or article intended to come into contact with food shall be manufactured in compliance with good manufacturing practice so that they do not transfer their constituents to food in quantities which could: endanger human health, cause an unacceptable change in the food composition, or bring about a deterioration in the organoleptic characteristics thereof. All subjects in the food production chain (producer/distributor/final user) are legally obliged to verify and respect the requirements of the legislation regarding FCMs.In line with law requirements, all Reflexx gloves are tested for overall and specific migration, using food simulants.