Nitrile Examination GlovesNewton™/Handsafe® Sensitive GN91

Product Type:Powder Free Nitrile Examination Gloves

Size X-Small Small Medium Large X-LargeProduct Code GN91 GN91 GN91 GN91 GN91NHS Code FTE1162 FTE1163 FTE1164 FTE1165 FTE1166

Gloves Specification:Material: NitrileSurface Finish: Finger texturedColour: BlueDesign: Ambidextrous. Latex free. Beaded cuff for addedstrength and easier donning. Strong, soft and flexible.Latex Free: Yes

Packing:Dispenser: 200 gloves per dispenser boxOuter Case: 10 dispensers per casePallet: 50 cases per pallet

Performance Specification:Freedom from holes - BS EN 455-1Water Tight Test General Inspection Level 1, AQL 1.5

Dimensions – BS EN 455-2 X-Small Small Medium Large X-Large Palm Width (mm) ≤ 80 80 ± 10 95 ± 10 110 ± 10 ≥ 110Length (mm) 240 min 240 min 240 min 240 min 240 min

Force at Break – BS EN 455-2Throughout shelf life Minimum 6 NewtonAfter challenge test Minimum 6 Newton

Biological Properties – BS EN 455-3Powder Level Less than 2 mg per gloveProtein Content (Latex only) ≤50μg/g using the modified Lowry method

Viral Penetration – ASTM F1671-7Phi-X174 Bacteriophage penetration No visual penetration

Shelf Life Properties – BS EN 455-4Currently shelf life is determined through accelerated ageing and is set at 3 years (whilst real time studies are in progress)

Chemical CompatibilityInformation regarding permeation of cytotoxic/chemotherapy drugs is available on request

Quality Standards:Manufacturing QMS EN ISO 9001 / EN ISO 13485Glove The BS EN 455 series of standards (parts 1,2,3 and 4)Sampling & Inspection ISO2859-1MDD Requirement Medical Devices Directive 93/42/EEC (and subsequent amendments)CE Classification Class I non-sterile Medical Device

Glove CareKeep away from direct sunlight or fluorescent light. Store at temperature no less than 5°C, no more than 25°C

XSXSXS

Packaging Artwork:

Inner Outer

Size Colour coding

X-Small Small Medium Large X-Large

Barcodes:

Size X-Small Small Medium Large X-Large

Inner 5024951016045 5024951016052 502951016069 5024951016076 5024951016083

Outer 5024951016090 5024951016106 5024951016113 5024951016120 5024951016137

Packaging Symbols:

g Lot number LATEX Latex free5:l25:

Temperature limitation

N Date of manufacture Powder free Recyclable packaging

H Use by Acceptable quality level p Keep dry

M ManufacturerCompliant with protective gloves general requirements

w Keep away from sunlight

Compliant with the Medical Devices Directive

Food Approved

Compliant with the Personal Protective Equipment Directive

Protection against chemical hazards

d Non sterileProtection against micro-organism and biological hazards

Nitrile Examination GlovesNewton™/Handsafe® Sensitive

262mm

375 mm

240m

m

GUIDETRANSPARENCY - DO NOT PRINT AS WHITE

BLACK

POWDER

Class IMedicalDevice

GN91/Feb 2013

Healthline Colwood House, 158 Garth Road, Morden, Surrey, England SM4 4LZ

020 8335 5213 (Office)

020 8335 5252

sales@healthline.co.uk

www.healthline.co.uk

Dimensions: Dispenser: 230mm W x 125mm L x 73mm HOuter: 375mm W x 262mm L x 240mm H

EN374 - 3: 2003

EN374-2:2003

F