Blue Nitrile Gloves Multipurpose
box of 100 pieces

CE

The CE marking (European Conformity marking) attests that the product meets the European Union rules and requirements for manufacturing and commercial marketing.

Medical device

Products can be used as medical devices in accordance with Directive 93/42/EEC (in accordance with EN 455 part 1,2 and 3) – 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. 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.

DPI-PPE

Personal Protective Equipment in accordance with the legislation on safety at work (in accordance with Decree 81/2008, Decree 475/92 in implementation of Directive 89/686/EEC and subsequent amendments). Reference standards EN420, EN374 part 1, 2 and 3.

Not natural rubber

The product does not contain natural rubber.

Products intended for contact with food

Products in accordance with Regulation 1935/2004/EC – DM 21.03.1973 and subsequent amendments related to products intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/CE. It applies to all materials and objects intended to come into contact with food. We conduct tests for specific Global Migration at specific time intervals and temperatures, using simulants substances, which emulate the extractive capacity of all edible food groups, like the chart below. We also check with specific Migrations tests that prohibited and / or specifically restricted chemicals do not to exceed the permitted levels (for example: Phthalates, vinyl chloride, acrylonitrile etc..). The “i” indicates the need to provide the users with additional informations about types of food, temperatures and times to which the glove has been tested.

Disposable products

Disposable products. To keep features and levels of protection the gloves can not be donned a second time.

EN 374-2 – Level 2

Products tested by European Community accredited laboratories and certified to protect against microorganisms.

The level of performance 2, shown below the pictogram, indicates an AQL for pinholes less than 1.5, considered an effective barrier against microbiological hazards (microorganisms). Even Directive 93/42/EEC (see above) which regulates the Medical Devices requires an AQL of less than 1.5 as a barrier for the biological fluids and microorganisms.

EN 374-3 – Level 3

Products tested by European Community accredited laboratories and certified to protect against specific chemicals, indicated by special symbols (eg. K= sodium hydroxide, L= sulfuric acid, G= diethylamine) for specified lapse of time called permeation times. For correct use see the Tech. Files available upon request.