Nitras 8310 medical datablad

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2. // ENSURE SAFETY MATERIAL PROPERTIES DESCRIPTION STANDARD BEFORE AGEING STANDARD AFTER AGEING ELONGATION AT BREAK (%) min. 600 (Guideline: min. 400) min. 500 (Guideline: min. 400) TENSILE STRENGTH (MPa) min. 18 (Guideline: min. 14) min. 20 (Guideline: min. 14) DIMENSIONS SIZE VALUES LENGTH (mm) all sizes min. 240 WIDTH OF THE PALM (mm) XS S M L XL 75 ± 5 85 ± 5 95 ± 5 105 ± 5 115 ± 5 STRENGTH (mm) all sizes Finger: 0,08 ± 0,03 (Guideline: 0,05) Palm: 0,06 ± 0,03 (Guideline: 0,06) Cuff: 0,04 ± 0,01 MCD MEDICAL CARE DENTAL GMBH | HEINRICH-HERTZ-STR. 11 | 50181 BEDBURG | GERMANY TELEFON: +49 2272 401 111 | FAX: +49 2272 401 200 | E-MAIL: info@nitras-medical.com | WEB: www.nitras-medical.com GESCHÄFTSFÜHRER: Maria Baric, Markus Seiler | HRB 83971 | Gerichtsstand Köln | USt.-IdNr.: DE299692222

3. MCD MEDICAL CARE DENTAL GMBH | HEINRICH-HERTZ-STR. 11 | 50181 BEDBURG | GERMANY TELEFON: +49 2272 401 111 | FAX: +49 2272 401 200 | E-MAIL: info@nitras-medical.com | WEB: www.nitras-medical.com GESCHÄFTSFÜHRER: Maria Baric, Markus Seiler | HRB 83971 | Gerichtsstand Köln | USt.-IdNr.: DE299692222 // ENSURE SAFETY DECLARATION OF CONFORMITY MCD Medical Care Dental GmbH Heinrich-Hertz-Str. 11 50181 Bedburg GERMANY We declare that the product described hereafter is in conformity with the provisions of Council Directive 93/42/EEC and the German Act on Medical Devices (MPG). The product is marked with the CE mark. PRODUCT SPECIFICATION Product designation: 8310 // WHITE WAVE Type: Nitrile diposable gloves, sizes XS-XL Classification according to annex IX of the regulation 93/42/EEC: Class I according to rule 1 and 5 CONFORMITY ASSESSMENT Procedures laid down by Directive 93/42/EEC: Annex VII APPLICABLE STANDARDS Harmonized standards | national standards | other standards: DIN EN ISO 9001:2008 EN ISO 13485:2012 EN 455 EN 374 Bedburg, 14.01.2016 ___________________________ Fr. Maria Baric Geschäftsführerin MCD Medical Care Dental GmbH

1. MCD MEDICAL CARE DENTAL GMBH | HEINRICH-HERTZ-STR. 11 | 50181 BEDBURG | GERMANY TELEFON: +49 2272 401 111 | FAX: +49 2272 401 200 | E-MAIL: info@nitras-medical.com | WEB: www.nitras-medical.com GESCHÄFTSFÜHRER: Maria Baric, Markus Seiler | HRB 83971 | Gerichtsstand Köln | USt.-IdNr.: DE299692222 // ENSURE SAFETY TECHNICAL DATASHEET 8310 // WHITE WAVE MATERIAL Nitrile, white COATING - SIZES XS-XL PACKAGING UNIT 1000 pieces (10 boxes à 100 pieces each) CERTIFICATION EN 374 DESCRIPTION NITRAS WHITE WAVE, nitrile disposable gloves, white, non-sterile, rolled edge, powder-free, tested according to EN 455, for food contact, ambidextrous, medical examination gloves, micro-roughened fingertips, AQL 1,5 STORAGE The products must be stored appropriately, this means in cartons in cool, dry rooms. External influences such as moisture, temperatures, light, as well as natural materical changes during a period could implicate change in the properties. DURABILITY see overpack MATERIAL MATERIAL COLOUR PALM Nitrile White INDEX FINGER AND THUMB Nitrile White BACK OF THE HAND Nitrile White KNUCKLES PROTECTION - - FINGER TIPS Nitrile White CUFF / KNITTED WRIST - - AQL 1,5 POWDER

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