new - Samco Products LTD - Specification New... · ProductRe-order X/Small Small Medium Large...
Transcript of new - Samco Products LTD - Specification New... · ProductRe-order X/Small Small Medium Large...
Product Re-order X/Small Small Medium Large X/Large
Product code GL8814 GL8811 GL8812 GL8813 GL8815
Latex Textured Medical Examination Gloves
PowderFree
Contains Latex
Class 1 Medical DeviceManufactured 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-002 - Rev01
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
MinorVisual 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 : 2000Glove: BS EN 455 Parts 1, 2 & 3Sampling: ISO 2859-1Medical Device Directive Requirement: 93/42/EEC Class 1PPE Directive Requirement: N/ATechnical File Requirements & Availability: Available for inspection by Brosch direct or their notified bodyShelf life: 3 years
newLATEX
Material specification: Natural rubber latexManufacturing process types: Online chlorination on donning surface and polymer coating on
working surfaceColour: Off white to yellowTexture and grip: Full palm-textured surface finished, good gripFormer type: E5 full palm-textured former
Glove Symbols
Latex Caution Statement:Safe use of this glove by or on latex sensitized individuals has not been established.This product contains natural rubber latex which may cause allergic reactions.
Dimensions X/Small Small Medium Large X/Large
Palmwidth (mm) ≤ 80 80 ± 10 95 ± 10 110 ± 10 ≥ 110
Length (mm) 240 minimum 240 minimum 240 minimum 240 minimum 240 minimum
Thickness (mm) palm 0.13 minimum 0.13 minimum 0.13 minimum 0.13 minimum 0.13 minimum
Thickness (mm) finger 0.15 minimum 0.15 minimum 0.15 minimum 0.15 minimum 0.15 minimum
Biological Evaluation BS EN 455-3 : 2000
Protein Test ≤ 50µg/g using the modified Lowry method
Residual Powder ASTMD6124-01
Physical properties BS EN 455-2 : 2000 N=13,MedianValue,Dumbbell sample width 3mm
Freedom from holes BS EN 455-1 : 2000
Water Tight Test General Inspection Level 1, AQL 1.5
Force AtBreak Test
BeforeAge Min. 9 Newton Min. 9 Newton Min. 9 Newton Min. 9 Newton Min. 9 Newton
AfterAge Min. 6 Newton Min. 6 Newton Min. 6 Newton Min. 6 Newton Min. 6 Newton
Powder Content Samples should contain no more than 1.0mg of any filterable residue per glove
Latex Textured Medical Examination Gloves
LATEX
Barcodes
Inner Dispensers
X/Small
Small
Medium
Large
X/Large
Outer Cartons
X/Small
Small
Medium
Large
X/Large
Packaging
Pantone Codes:X/Small = Pantone 667Small = Pantone 221Medium = Pantone Reflex BlueLarge = Pantone 329X/Large = Pantone 491Red = Pantone 485Orange = Pantone 1585
Inner DispenserArtwork
Outer Carton Artwork
new
PackagingMaterial Specification
Inner Dispenser 450 gsm grey back
Outer Carton Textliner 175gsm/175gsm B-flute
Packaging Size
Inner DispenserWindow size
246mm (L) x 132mm (W) x 79mm (H)130mm (L) x 47mm (W)
Outer Carton412mm (L) x 270mm (W)x 257mm (H)
Brosch UK Head Office Technical Contact Details
Contact Kevin Roberts
Address Harrier Park, Southgate Way, Orton Southgate, Peterborough, Cambridgeshire, PE2 6YQ
Tel no. +44 (0) 1733 230 230 Email [email protected]
BroschMalaysia Technical Contact Details
Contact KK Ngan
Address 3 Jalan Wawasan 3/5, Pusat Bandar Puchong, 47100 Puchong, Selangor, Malaysia
Tel no. +60 12 2106738 Email [email protected]
Lot Numbering Requirements: Brosch direct standard LOT numbering systemTesting 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 100 Gloves per Dispenser. Sample N=8. Acceptance criteria: ≥ 98% average quantity
Outer Carton 10 Dispensers per Carton
Pallet 500 Dispensers (10 x 50 Cartons)