Sterile Orange Nitrile 300 DI

Description | Features | Fact Sheets | Purchase Information 

Description

Powder Free cleanroom laundered Handspecific Sterile 30 cm Nitrile Gloves PPE Category III (Complex Design) according to Council Directive 89/686/EEC Fully compliant to the latest PPE norms - EN374:2003 “Protective gloves against chemicals and micro-organisms”.

Material

Synthetic soft nitrile polymer (Acrylonitrile Butadiene) with blend of Polychloroprene, based on Skin Nitrile™ technology. Contains no natural rubber latex.

Design

Orange, handspecific, beaded cuff, with textured palm and fingers.

Packaging

Packaging designed to comply with sterile processing environments. Gloves pair packed in a sealed polyethylene pouch. Twenty (20) pouches per sealed (double) poly bag. Ten (10) poly bags per double walled shipping case. Total of 200 pairs per outer case.

Quality Systems

Manufactured in accordance with ISO 9001:2000 and ISO 13485:2003.

Features

• Biocompatibility demonstrated by Modified Buehler and Primary Skin Irritation Tests.
• Non detectable levels of chemical accelerators using aqueous solution extraction (Phosphate buffered solution) and High Performance Liquid Chromatography (HPLC) assay method for quantitative analysis.
• Free of Thiurams, Thiazoles and Dithiocarbamates – these chemical accelerators are excluded from the manufacturing process.
• Micro-organism and virus resistant – passes highest level of micro-organism resistance per EN374-2: 2003 (Performance level 3, AQL <0.65 and inspection level G1 according to 1000ml water test) and passes viral penetration test using Phi-X 174 bacteriophage (ASTM F1671-97b).
• Terminally sterilized by gamma irradiation to Sterility Assurance Level (SAL) of 10-6, in accordance with guidelines detailed in ANSI/AAMI / EN ISO 11137:2006 “Sterilization of Healthcare Products – Radiation”.
• Compatible with sterile processing environments due to paperless packaging and multiple post leaching of gloves.
• NVR: maximum 30mg/g (IEST-RP-C0005.3).
• FTIR: non detectable levels of silicone, amide and DOP (IEST-RP-C0005.3).
• Low Endotoxin content at <20 EU/pair (EN455-3:2006) demonstrated by Limulus Amoebocyte Lysate (LAL) kinetic turbidimetric test.

Fact Sheets

Purchase information