MEDICAL DEVICES

Products can be used as medical devices in accordance with Directive 93/42/EEC (in accordance with EN 455 part 1,2,3 and 4) – Directive 93/42/EEC on Medical Devices, provides the requirements for the production of gloves to be worn in health care (and therefore for dental use), as well as labelling requirements and assessment of biosafety and validity. The gloves considered Medical Devices provide protection from cross contamination for both the patient and the user as they are considered an effective barrier to fluids and microorganisms.