Nitrile Examination Gloves Handsafe® GN80
Transcription
Nitrile Examination Gloves Handsafe® GN80
Nitrile Examination Gloves Handsafe GN80 ® Product Type: Powder Free Nitrile Examination Gloves Size Product Code Small GN80 Medium GN80 Large GN80 X-Large GN80 Gloves Specification: Material: Nitrile Surface Finish: Finger textured Colour: Black Design: Ambidextrous. Latex free. Beaded cuff for added strength and easier donning. Strong soft and flexible Latex Free: Yes Packing: Dispenser: 100 gloves per dispenser box Outer Case: 10 dispensers per case Pallet: 75 cases per pallet Performance Specification: Freedom from holes - BS EN 455-1 General Inspection Level 1, AQL 1.5 Water Tight Test Dimensions – BS EN 455-2 Palm Width (mm) Length (mm) Small 80 ± 10 240 min Medium 95 ± 10 240 min Large 110 ± 10 240 min Force at Break – BS EN 455-2 Throughout shelf life After challenge test Minimum 6 Newton Minimum 6 Newton Biological Properties – BS EN 455-3 Powder Level Protein Content (Latex only) Less than 2 mg per glove ≤50μg/g using the modified Lowry method X-Large ≥ 110 240 min Viral Penetration – ASTM F1671-7 Phi-X174 Bacteriophage penetration No visual penetration Shelf Life Properties – BS EN 455-4 Currently shelf life is determined through accelerated ageing and is set at 3 years (whilst real time studies are in progress) Quality Standards: Manufacturing QMS Glove Sampling & Inspection MDD Requirement CE Classification Glove Care EN ISO 9001 / EN ISO 13485 The BS EN 455 series of standards (parts 1,2,3 and 4) ISO2859-1 Medical Devices Directive 93/42/EEC (and subsequent amendments) Class I non-sterile Medical Device Keep away from direct sunlight or fluorescent light. Store at temperature no less than 5°C, no more than 25°C Nitrile Examination Gloves Handsafe GN80 ® Packaging Artwork: InnerOuter 220mm SV DA FI NO RO BG AR 60mm Undersökningshandskar i Nitril - svart - Puderfria Nitril undersøgelseshandske - sort - Pudderfri Nitriili tutkimuskäsineet - musta - Puuteroimaton Nitrile undersøkelseshansker - sort - Pudderfri Mănuși examinare Nitril - negre - Fără pudra Ръкавици медицински стерилни - черни - без пудра ﺑﺪﻭﻥ ﺑﻮﺩﺭﺓ- ﺃﺳﻮﺩ- ﻧﻴﺘﺮﻳﻞ- ﻓﺤﺺ ﺍﻟﻘﻔﺎﺯﺍﺕ GN80 Black Nitrile Examination Gloves - Powder Free 230mm approx. by weight 100 S DE FR ES NL PT CS PL 100 approx. by weight 60mm Manufactured in accordance with Class 1 Medical Devices Directive 93/42/EEC SV DA FI NO RO BG AR S S S 100 approx. by weight Size Colour coding 5 024951 013693 > GN80 Black Nitrile Examination Gloves Powder Free approx. by weight 100 GN80 Black Nitrile Examination Gloves - Powder Free Undersökningshandskar i Nitril - svart - Puderfria Nitril undersøgelseshandske - sort - Pudderfri Nitriili tutkimuskäsineet - musta - Puuteroimaton Nitrile undersøkelseshansker - sort - Pudderfri Manusi examinare Nitril - negre - Fara pudra Ръкавици медицински стерилни - черни - без пудра ﺑﺪﻭﻥ ﺑﻮﺩﺭﺓ- ﺃﺳﻮﺩ- ﻧﻴﺘﺮﻳﻞ- ﻓﺤﺺ ﺍﻟﻘﻔﺎﺯﺍﺕ approx. by weight 100 S GN80 Black Nitrile Examination Gloves Powder Free 120mm Nitril-Untersuchungshandschuhe - schwarz - Puderfrei Gants d'examen Nitrile - noir - Non poudré Guantes de examen en Nitrilo - negro - Sin polvo Nitrile onderzoekhandschoenen - zwart - Ongepoederd Luvas de examen de Nitrilo - preto - Sem pó Rukavice vyšetřovací Nitrilové - černé - Bez pudru Nitrylowe rękawice diagnostyczne - czarne - Bezpudrowe 5 024951 013693 > open here Small Medium Large X-Large GN80 Black Nitrile Examination Gloves - Powder Free DE FR ES NL PT CS PL Nitril-Untersuchungshandschuhe - schwarz - Puderfrei Gants d'examen Nitrile - noir - Non poudré Guantes de examen en Nitrilo - negro - Sin polvo Nitrile onderzoekhandschoenen - zwart - Ongepoederd Luvas de examen de Nitrilo - preto - Sem pó Rukavice vyšetřovací Nitrilové - černé - Bez pudru Nitrylowe rękawice diagnostyczne – czarne – Bezpudrowe Compliant with the Medical Devices Directive 93/42/EEC and European Standard EN455: Medical Gloves for Single Use. Manufactured to meet EN455 Parts 1, 2, 3 and 4. Compliant with the Personal Protective Equipment Directive 89/686/EEC and European Standard EN420: Protective Gloves. Classification CAT III waterproof gloves and low chemical resistance (not reflecting duration of protection). PPE type examination conducted by British Standards Institute (0086). Safe for food use - compliant with Regulation (EC) 1935/2004 and Commission Regulation 10/2011 Plastic materials and articles intended to come into contact with food. Conforme à la directive médicale 93/42/CEE et la norme européenne EN455: Gants médicaux à usage unique. Fabriqué selon la norme EN455, parties 1, 2, 3 et 4. Conforme à la directive EPI 89/686/CEE et la norme européenne EN420: Gants de protection. Classification CAT III: étanchéité et resistance chimique légère. Certification BSI (0086). Certifié agroalimentaire - conforme au règlement (CE) 1935/2004 et règlement de la Commission 10/2011 Matières plastiques et objets destinés à entrer en contact avec les aliments. WARNING: Contains ZDBC and ZDEC chemicals, which can cause type IV skin irritation and contact dermatitis. ATTENTION: Contient les chimiques ZDBC et ZDEC qui peuvent causer des irritations type IV de la peau. ACHTUNG: Enthält ZDBC und ZDEC Chemikalien, der Typ IV allergische Reaktionen auslösen kann. Made in: S GN80 EN455 M GN80 L GN80 EN420 XL GN80 EN374 120mm Konform mit der Richtlinie 93/42/EWG für Medizinprodukte und der europäischen Norm EN 455 Medizinische Handschuhe zum einmaligen Gebrauch. Hergestellt gemäß der Normen EN455 Teil 1, 2, 3 und 4. Konform mit der Richtlinie PSA 89/686/EWG und der Europäischer Norm EN420-Schutzhandschuhe. Kat III Klassifikation: Penetrationsprüfung und geringer Chemikalien Schutz. BSI Bescheinigung (0086). Lebensmittelgeprüft - konform mit der Verordnung (EG) 1935/2004 und der Verordnung 10/2011 der Kommission Kunststoff-Materialien und Gegenstände, die mit Lebensmitteln in Berührung zu kommen. Dimensions: Dispenser: L220mm x W120mm x H60mm Outer: L315mm X W248mm X H230mm g H N h GN80 S CAT III For single use only. Keep in a cool dry place, away from direct sunlight or fluorescent light Pour usage unique seulement. Entreposer dans un endroit frais et sec, à l’abri de la lumière du soleil et de l’éclairage fluorescent Nur zum einmaligen Gebrauch. Kühl und trocken lagern. Direktes Sonnenlicht und fluoreszierendes Licht vermeiden M HPCHL, PO Box 85, SM4 9AW, UK. 0086 BSI, Milton Keynes, MK5 8PP EN420 Penetration: Level 2 Handsafe-GN80-2 220mm Dimensions: 220x120x60mm Barcodes: COLOUR GUIDE Size Small Medium Large X-Large Inner 5024951013693 5024951013709 5024951013716 5024951013723 Outer 5024951013730 5024951013747 5024951013754 5024951013761 100% BLACK (K) GUIDE PANTONE 186 C Packaging Symbols: g N H M Class I Medical Device Lot number LATEX Latex free Date of manufacture POWDER Powder free Use by Acceptable quality level Manufacturer Compliant with Protective Gloves general requirements EN420 Compliant with the Medical Devices Directive Compliant with the Personal Protective Equipment Directive Non sterile D Single use - do not re-use GN80/June 2014 l25: Temperature limitation Recyclable packaging p w Keep dry Keep away from sunlight Food Approved EN374-2:2003 F EN374 - 3: 2003 d 5: Protection against micro-organism and biological hazards Protection against chemical hazards Healthline Colwood House, 158 Garth Road, Morden, Surrey, SM4 4LZ England 020 8335 5213 (Office) 020 8335 5252 [email protected] www.healthline.co.uk