Chemical and Micro-Organism EN374
EN374-2 Resistance to penetration by micro-organisms.
Referred to as acceptable quality level (AQL) 1-3
EN374-3 Resistance to chemical hazards 1-6
Product is made from food approved ingredients.
Migration testing is performed to ensure that the article in contact with food meets the required standards.
If both of these criteria are met, the food contact symbol can be applied to the glove and/or packaging.
Medical Devices Directive
Medical devices directive 93/42/EEC classifies devices according to the potential hazard, expected duration of contact and expected invasiveness.
If a product conforms to the medical devices directive it must carry a CE mark on its packaging, and may also provide a statement of its classification.
In addition, the properties of medical devices are described by a range of standards.
Classification of devices
Class I Non-invasive devices, for example examination gloves (entry into a bodily orifice is not considered invasive)
Class I – Sterile Sterilised class I devices, for example sterile procedure gloves.
Class IIa With respect to the portfolio of Polyco Healthcare products these are short term invasive devices, for example surgical gloves.
European Standards for Medical Gloves
All Polyco Healthcare Medical Gloves comply with the European Standard EN455 Medical Gloves for single use.
The standard is divided into 4 parts covering:
EN455-1 – Freedom from holes
EN455-2 – Physical properties
EN455-3 – Requirements for bio compatibility and labeling
EN455-4 – Requirements and testing for shelf life determination
For Minimal Risk Only
Gloves of Simple design offer protection from low level risks, e.g. janitorial gloves.
Manufacturers are permitted to test and self-certify the gloves themselves.
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