Brosch Direct Healthcare & Janitorial Supplies · Outer Carton Artwork Packaging Material...
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Product Re-order X/Small Small Medium Large X/Large Product code G1900XS G1900S G1900M G1900L G1900XL Nutouch 1.5 Blue Nitrile Powder Free Examination Gloves Latex Free Class 1 Medical Device Manufactured to BS EN 455 Single Use Lot/Batch Number Use By Date Date of Manufacture Manufactured By Storage Temperature Avoid Direct Sunlight/ Fluorescent Light Avoid Damp Storage Packaging Recyclable LBPS-165 - Rev03 Product Type: Powder free ambidextrous non-sterile examination glove Visual Defects Acceptance Criteria and AQL Levels Major Visual Defects G-1, AQL 2.5 • Insect • Mix size • Dirt/Stain ≥2.5mm 2 • Torn • Mix Type • Sticky • Touching • Donning • Wet look • Former knocking • Mixed colour • Lumps ≥2.5mm 2 • Visible hole • Discoloration • Hair/Foreign matter Minor Visual Defects G-1, AQL 4.0 • Thin spots • Wet look • Double dipped • Stain/Dirt ≤2.5mm 2 • Lump ≤2.5mm 2 • Sticky • Poor beading Quality Standards (ISO BS EN) Expectation Manufacturing QMS: BS EN ISO 9001 / BS EN ISO 13485 Sampling: ISO 2859-1 Medical Device Directive: 93/42/EEC and subsequent amendments. EN455 series of standards. CE Class I Medical Device. Personal Protective Equipment Directive: 89/686/EEC. EN420 and EN374 series of standards. CE 0086 Category III Technical File Requirements & Availability: Available for inspection by Brosch direct or their notified body Shelf life: 3 years NITRILE Material specification: Acrylonitrile butadiene Manufacturing process types: Online chlorination on donning surface and polymer coating on working surface Colour: Blue Texture and grip: Finger textured with light grip Former type: E4 finger-textured former Glove Symbols Dimensions X/Small Small Medium Large X/Large Palm width (mm) ≤ 80 80 ± 10 95 ± 10 110 ± 10 ≥ 110 Length (mm) 240 minimum 240 minimum 240 minimum 240 minimum 240 minimum Thickness (mm) palm 0.07 minimum 0.07 minimum 0.07 minimum 0.07 minimum 0.07 minimum Thickness (mm) finger 0.1 minimum 0.1 minimum 0.1 minimum 0.1 minimum 0.1 minimum Residual Powder ASTM D6124-01 Physical properties BS EN 455-2 : 2009 + A2 : 2013 N=13, Median Value, Dumbbell sample width 3mm Freedom from holes BS EN 455-1 : 2000 Water Tight Test General Inspection Level 1, AQL 1.5 Powder Content Samples should contain no more than 2.0mg of any filterable residue per glove POWDER FREE 1.5 Level 2 Force At Break Test Throughout Shelf Life Min. 6 Newton Min. 6 Newton Min. 6 Newton Min. 6 Newton Min. 6 Newton Food Safe Food safe gloves (EC 1935/2004 and European Regulation 10/2011, except fatty food). Food Safe
Transcript of Brosch Direct Healthcare & Janitorial Supplies · Outer Carton Artwork Packaging Material...
Product Re-order X/Small Small Medium Large X/Large
Product code G1900XS G1900S G1900M G1900L G1900XL
Nutouch 1.5 Blue Nitrile Powder Free Examination Gloves
Latex Free
Class 1 Medical Device Manufactured to BS EN 455
Single Use
Lot/Batch Number
Use By Date
Date of Manufacture
Manufactured By
Storage Temperature
Avoid Direct Sunlight/Fluorescent Light
Avoid Damp Storage
Packaging Recyclable
LBPS-165 - Rev03
Product Type: Powder free ambidextrous non-sterile examination glove
Visual Defects Acceptance Criteria and AQL Levels
Major Visual Defects G-1, AQL 2.5• Insect • Mix size • Dirt/Stain ≥2.5mm2
• Torn • Mix Type • Sticky• Touching • Donning • Wet look• Former knocking • Mixed colour • Lumps ≥2.5mm2
• Visible hole • Discoloration • Hair/Foreign matter
Minor Visual Defects G-1, AQL 4.0• Thin spots • Wet look • Double dipped• Stain/Dirt ≤2.5mm2 • Lump ≤2.5mm2
• Sticky • Poor beading
Quality Standards (ISO BS EN) Expectation
Manufacturing QMS: BS EN ISO 9001 / BS EN ISO 13485 Sampling: ISO 2859-1Medical Device Directive: 93/42/EEC and subsequent amendments. EN455 series of
standards. CE Class I Medical Device.Personal Protective Equipment Directive: 89/686/EEC. EN420 and EN374 series of standards.
CE 0086 Category IIITechnical File Requirements & Availability: Available for inspection by Brosch direct or their notified bodyShelf life: 3 years
NITR
ILE
Material specification: Acrylonitrile butadieneManufacturing process types: Online chlorination on donning surface and polymer coating on
working surfaceColour: BlueTexture and grip: Finger textured with light gripFormer type: E4 finger-textured former
Glove Symbols
Dimensions X/Small Small Medium Large X/Large
Palm width (mm) ≤ 80 80 ± 10 95 ± 10 110 ± 10 ≥ 110
Length (mm) 240 minimum 240 minimum 240 minimum 240 minimum 240 minimum
Thickness (mm) palm 0.07 minimum 0.07 minimum 0.07 minimum 0.07 minimum 0.07 minimum
Thickness (mm) finger 0.1 minimum 0.1 minimum 0.1 minimum 0.1 minimum 0.1 minimum
Residual Powder ASTM D6124-01
Physical properties BS EN 455-2 : 2009 + A2 : 2013 N=13, Median Value, Dumbbell sample width 3mm
Freedom from holes BS EN 455-1 : 2000
Water Tight Test General Inspection Level 1, AQL 1.5
Powder Content Samples should contain no more than 2.0mg of any filterable residue per glove
POWDERFREE
1.5
Level 2Force AtBreakTest
ThroughoutShelf Life
Min. 6 Newton Min. 6 Newton Min. 6 Newton Min. 6 Newton Min. 6 Newton
Food Safe Food safe gloves (EC 1935/2004 and European Regulation 10/2011, except fatty food).
Food Safe
Nutouch 1.5 Blue Nitrile Powder Free Examination Gloves
NITR
ILE
Barcodes
Inner Dispensers
X/Small
Small
Medium
Large
X/Large
Outer Cartons
X/Small
Small
Medium
Large
X/Large
Packaging
Inner Dispenser Artwork
Outer Carton Artwork
Packaging Material Specification
Inner Dispenser 450 gsm grey back
Outer Carton Textliner 175gsm/175gsm B-flute
Packaging Size
Inner DispenserWindow size
230mm (L) x 125mm (W) x 73mm (H)130mm (L) x 40mm (W)
Outer Carton375 mm (L) x 262mm (W) x 240mm (H)
Brosch direct Head Office Technical Contact Details
Contact Karen Gunning
Address South Fen Road, Bourne, Lincolnshire, PE10 0DN
Tel no. 01733 405 581 Email [email protected]
Lot Numbering Requirements: Brosch direct standard LOT numbering system
Testing Requirements & Frequency:Each size and LOT will be tested by the manufacturer to BS EN 455. Shipment release will be authorised by Brosch directQA department. Independent tests will be carried out in accordance with the Brosch direct statistical sampling plan.
Quantities
Inner Dispenser 200 Gloves per Dispenser. Sample N=8. Acceptance criteria: ≥ 98% average quantity
Outer Carton 10 Dispensers per Carton
Pallet 500 Dispensers (10 x 50 Cartons)
1.5
