Other Features
100% inspected and air leak tested Suitable for autoclaving Can be sanitized by VHP or IPA
Protein Level
Nitrile contains no natural latex proteins
Packing
Bagged
Particulates
Tested according to IEST-RP-CC-005.3
Physical Properties
Complies with the requirements of Standards EN 420, EN 374 & EN 455-2. ASTM D6978-05 tested against cytotoxic drugs
Sterile
Sterile
Quality Systems
Manufactured in a facility holding ISO 9001:2008 certification. Processed in an NEBB certified ISO Class 4 cleanroom environment
Sampling & Inspection
100% inspection and air leak tested
Shelf Life and Storage
Three (3) years from date of manufacture. Store in a dry, cool place (<40°C) away from direct sunlight and fluorescent light.
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 bag and the carton to provide product traceability
Product Type
Sterile Mitten
Compatibility
ISO Class 4 & EU GMP Grade A
Regulatory Classification
Category 3 - Complex Design Personal Protective Equipment conforming to PPE Directive 89/686/EEC
BioClean BarrierPlus™ mittens are manufactured from accelerator-free nitrile with incredibly low levels of particles and excellent ESD properties. Designed for RABS, where interventions are rae and access speed is critical, BarrierPlus mittens are the cost effective alternative to gauntlets. Fully validated for sterility with an SAL (Sterility Assurance Level) of 10-6 and are available in lengths of up to 840mm (33”) and suitable for port sizes from 230mm to 265mm (9.0” to 10.5”).
