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BM Polyco Puncture Resistant Gloves - Catalogue - Reid Brothers

BM Polyco Puncture Resistant Gloves - Catalogue - Reid Brothers

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Explanation of Standards used within this category(further explanation can be found at the front of this catalogue)Chemical and Micro-Organism EN374RatingEN374-2 Resistance to penetration by 1-3micro-organisms. Referred toas acceptable quality level (AQL)EN374-3 Resistance to chemical hazards 1-6Food ContactProduct is made from food approved ingredients. Migration testing isperformed to ensure that the article in contact with food meets therequired standards. If both of these criteria are met, the Food Contactsymbol can be applied to the glove and/or packaging.Medical Devices DirectiveMedical Devices Directive 93/42/EEC classifies devices according to the potential hazard, expected duration of contactand expected invasiveness. If a product conforms to the Medical Devices Directive it must carry a CE mark on itspackaging, and may also provide a statement of its classification. In addition, the properties of medical devices aredescribed by a range of standards.Classification of DevicesClass IClass I - SterileClass IIaNon-invasive devices, for example examination gloves (entry into a bodily orifice is notconsidered invasive).Sterilised class I devices, for example sterile procedure gloves.With respect to the portfolio of <strong>Polyco</strong> Healthcare products these are short term invasivedevices, for example surgical gloves.European Standards for Medical <strong>Gloves</strong>All <strong>Polyco</strong> Healthcare Medical <strong>Gloves</strong> comply with the European Standard EN455 Medical <strong>Gloves</strong> for Single Use. Thestandard is divided into 4 parts covering:EN455-1 – Freedom from holes.EN455-2 – Physical properties.EN455-3 – Requirements for biocompatibility and labelling.EN455-4 – Requirements and testing for shelf life determination.For Minimal Risk Only<strong>Gloves</strong> of simple design offer protection from low level risks, e.g. janitorial gloves.Manufacturers are permitted to test and self-certify the gloves themselves.<strong>Gloves</strong> of this category are CE-marked as follows:For Minimal Risk OnlyiThe higher the score, the better the performance.0 represents a fail - X denotes no test was carried out.142

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