Cleanroom

Other Features:

Powder-free, latex-free, beaded cuff, accelerator free. Part of the BioClean-C Chemotherapy range.

Protein Level:

Nitrile contains no natural latex proteins.

Sterilisation Method:

Gamma irradiation.

Packing:

Bagged

AQL:

1.5 freedom from pinholes (1000ml water test).

Particulates:

Processed in a cleanroom environment to ensure compatibility with ISO Class 4 & EU GMP Grade A operating conditions.

Physical Properties:

Complies with the requirements of the Glove Standard EN420:2003 and the European Medical Gloves Standard EN455 (Parts 1, 2 & 3) & EN374-1, 2 & 3:2003. ASTM 6978-05 tested against cytotoxic drugs.

Quality Systems:

Manufactured in a facility holding ISO 9001:2008 and 89/686/EEC Article 11b certifications. Processed in an NEBB certified ISO Class 4 cleanroom environment.

Sampling & Inspection:

In accordance with ISO 2859.

Storage Instructions:

Store in a dry, cool place (<40°C) away from direct sunlight and fluorescent light.

Shelf Life:

Five (5) years from date of manufacture.

Bar Codes:

Each size carries a unique bar code on the carton (ITF-14) to allow automatic data entry into Stock Control Systems.

Lot Number:

This is shown on the sealed pouch and carton to provide product traceability.

Packaging:

One cuffed pair per plastic wallet;
One wallet per EasyTear™ PE pouch;
10 pairs per sealed outer PE bag;
20 outer bags per carton liner;
One carton liner per carton (200 pairs).

Compatibility:

ISO Class 4 & EU GMP Grade A.

Regulatory Classification:

Category 3 - Complex Design Personal Protective Equipment conforming to PPE Directive 89/686/EEC.

Product Codes
and Sizes:

BENS6.0: 6.0
BENS6.5: 6.5
BENS7.0: 7.0
BENS7.5: 7.5
BENS8.0: 8.0
BENS8.5: 8.5
BENS9.0: 9.0
BENS10.0: 10.0