Cleanroom

Other Features:

Powder-free, beaded cuff, anatomical shape.

Protein Level:

Less than 50µg/gram.

Sterilisation Method:

Gamma irradiation.

Packing:

Bagged

AQL:

1.5 for 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, the European Medical Gloves Standard EN455 (Parts 1, 2 & 3) & EN374-1, 2 & 3:2003.

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 the carton to provide product traceability.

Packaging:

One cuffed pair per plastic wallet;
One wallet per EasyTear™ PE bag;
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:

BELS-60: 6.0
BELS-65: 6.5
BELS-70: 7.0
BELS-75: 7.5
BELS-80: 8.0
BELS-85: 8.5
BELS-90: 9.0