BioClean ADVANCE™
The quality all round latex glove, manufactured and designed for use in sterile critical environments, is ideal for those who demand a sterile glove with excellent comfort and fit.
Packaging
The non-shedding pouch virtually eliminates the particulate contamination traditionally associated with paper packaging. Each pair is processed in an ISO Class 4, EU GMP Class A compatible cleanroom and packed in a pouch that has been printed with IPA resistant ink.
Sterility
With full sterility validation, the BioClean Advance™ are double bagged and sealed to ensure sterility is maintained after irradiation. Regular validations in line with ISO 11137 are also carried out to ensure ongoing sterility.
Comfort & Protection
The BioClean Advance™ is a microtextured glove that has been anatomically designed to provide outstanding fit and comfort while reducing wearer fatigue. Low protein levels ensure that latex allergies are reduced, while it´s 300mm (12”) length provides
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Colour:
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Natural
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Length:
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300mm (12")
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Material
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Natural rubber latex.
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Type:
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Hand specific
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Surface:
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Textured.
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Other Features:
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Powderfree, anatomical shape, beaded cuff.
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Protein Level:
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Less than 50 µg/gram.
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Sterilisation Method:
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Gamma Irradiation.
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Packing:
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Bagged
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AQL:
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1.5 for holes (1000ml water test).
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Particulates:
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Processed in a cleanroom environment to ensure compatibility with ISO Class 4 & EU GMP Grade A operating conditions.
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Extractables:
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Extended leaching in pure de-ionised water ensures low levels of chlorides and extractable metals.
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Physical Properties:
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Manufactured to exceed the requirements of the PPE Gloves Standard EN420:2003 and the European Medical Gloves Standard EN455 (Parts 1, 2 & 3).
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Quality Systems:
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Manufactured in a facility holding ISO 9001:2000 and 89/686/EEC Article 11b certifications.
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Sampling & Inspection:
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In accordance with ISO 2859.
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Storage Instructions:
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Store in a dry, cool place (<40°C) away from direct sunlight and fluorescent light.
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Shelf Life:
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Five (5) years from date of manufacture.
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Bar Codes:
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Each size carries a unique bar code on the carton (ITF-14). This allows automatic data entry into Stock Control Systems.
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LOT Number
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This is shown on the sealed pouch and outer carton to provide product traceability.
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Packaging:
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One cuffed pair per inner plastic wallet;
One inner wallet per 'Easy Tear' PE bag;
10 pairs per sealed outer PE bag;
20 outer bags per carton liner;
One carton liner per carton (200 pairs).
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Compatibility:
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ISO Class 4 & EU GMP Grade A.
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Regulatory Classification:
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Category 3 - Complex Design Personal Protective Equipment conforming to EN420:2003 & EN374-1 & 2:2003.
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Order-Code
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Size
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Package
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4093-BASL 60
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6,0
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20x10Pair
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4093-BASL 65
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6,5
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20x10Pair
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4093-BASL 70
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7,0
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20x10Pair
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4093-BASL 75
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7,5
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20x10Pair
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4093-BASL 80
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8,0
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20x10Pair
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4093-BASL 85
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8,5
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20x10Pair
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4093-BASL 90
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9,0
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20x10Pair
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4093-BASL 100
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10,0
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20x10Pair
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