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AL300

Product catalog summary

About the Product:
BioClean Alpha Sterile Latex Gloves (AL300) are designed for exceptional flexibility and comfort. They feature an anatomically shaped design and an extra thick beaded cuff to enhance strength and reduce tearing during donning.

Specifications:

Compatibility: ISO Class 4 & EU GMP Grade A
Length: 300mm (12 inches)
Material: Latex
Protein Level: Less than 50µg/gram
Surface: Textured
Shape: Hand specific
Colour: Natural
Sterilization: Gamma irradiation

Features:

Exceptional flexibility and comfort
Extra thick beaded cuff to reduce tearing
Powder-free
EasyOn technology for easy double-donning
Non-particulating EasyTear packaging

Quality Standards:

Manufactured in ISO 9001:2015 and (EU)2016/425 Module D certified facilities
Conforms to Category 3 PPE Regulation (EU)2016/425
Processed in an NEBB certified ISO Class 4 environment
Complies with EN420:2003 +A1:2009, EN374-1:2016, EN374-5:2016, EN455-2:2015
Sterilized according to ISO 11137-1:2006
Suitable for contact with dry, alcoholic, and acidic foodstuffs
Complies with EN 421 for protection against particulate radioactive contamination

Sterilization:

Method: Gamma irradiation
Minimum Dose: 25kGy
Sterility Assurance Level: 10^-6

Shelf Life & Storage:

Five years from the date of manufacture
Store in a dry, cool place (<40°C) away from direct sunlight and fluorescent light

Physical Properties:

Freedom From Holes: AQL 0.65
Glove Length: 290mm +/-10mm
Single Wall Thickness: Cuff 6.30/0.16, Palm 7.09/0.18, Finger Tip 7.87/0.20 (mils/mm)
Force At Break: ≥9 N during shelf life

Glove Cleanliness Characteristics:

Typical Particle Count: <3500 counts/cm²
Typical Extractable Ions: Various anions and cations measured in µg/cm²

Warnings:

Contains natural rubber latex which may cause allergic reactions
No glove provides complete protection against all chemicals
Specific gloves must be selected for use with cytotoxic drugs

Contact Information:

Nitritex Ltd, UK
Ansell US, USA
Nitritex (M) Sdn.Bhd, Malaysia

Catalog excerpts

About BioClean Alpha Sterile Latex Gloves provide exceptional flexibility, and are anatomically shaped for enhanced wearer comfort. An extra thick beaded cuff adds strength and stability on the arm, and reduces the risk of the gloves tearing when donning. Specifications COMPATIBILITY: ISO Class 4 & EU GMP Grade A LENGTH: 300mm (12") MATERIAL: Latex PROTEIN LEVEL: Less than 50jug/gram SURFACE: Textured SHAPE: Hand specific COLOUR: Natural STERILIZATION: Gamma irradiation Features • Exceptional flexibility and comfort • Extra thick beaded cuff to reduce tearing when donning • Powder-free • EasyOn technology allows for easy double-donning • Non-particulating EasyTear packaging BIOCLEAN ALPHA Sterile Latex Gloves AL300 EXTRA THICK CUFF ANATOMICALLY SHAPED EXCEPTIONAL FLEXIBILITY & COMFORT DOUBLE-DONNABLE

Open the catalog to page 1

Quality Standards Sterilization • Manufactured in a facility holding ISO 9001:2015 and (EU)2016/425 Module D certifications • Conforms to Category 3 - Complex Design Personal Protective Equipment PPE Regulation (EU)2016/425 • Processed in an NEBB certified ISO Class 4 environment • Complies with the requirements of European Glove Standards EN420:2003 +A1:2009 and EN374-1:2016, EN374-5:2016 • Physical properties comply with European Medical Glove Standard EN455-2:2015 • Sterilized in accordance with ISO 11137-1:2006 • Suitable for contact with dry, alcoholic and acidic foodstuffs. Regulation (EC)1935/2004...

Open the catalog to page 2

Glove Cleanliness Characteristics TO ORDER Re-order code AL300-60 AL300-65 AL300-70 AL300-75 AL300-80 AL300-85 AL300-90 Packing One pair per inner PE wallet; one wallet per sealed EasyTear PE pouch; 10 pouches per sealed outer PE bag; 20 outer bags per lined carton (200 pairs) For additional information visit us at Nitritex Ltd Minton Enterprise Park Oaks Drive Newmarket, Suffolk CB87YY United Kingdom Tel: +44 1638 663338 www.bioclean.com, or contact us at; Ansell US 111 Wood Avenue South Suite 210 Iselin, NJ 08830 USA Tel: +1 800 800 0444 Nitritex (M) Sdn.Bhd 2 Jalan Jurunilai U1/20 Seksyen...

Open the catalog to page 3

All BioClean catalogs and technical brochures

*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.

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