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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 k.roberts@broschdirect.com

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 ngankk@myjarung.net

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)