SHIELDskin XTREME™ White Sterile Nitrile 600 DI+ Cleanroom Gloves – Extra Long, PPE Category III

SHIELDskin XTREME™ White Sterile Nitrile 600 DI+ are sterile, extra-long nitrile cleanroom gloves designed for high bio-contamination control in critical and controlled environments. The gloves are intended for demanding cleanroom applications where extended coverage, low particle generation, low endotoxin levels and validated sterility are required.

The gloves are manufactured from a synthetic soft nitrile polymer and are hand-specific, powder-free and triple DI washed. Clean processing includes multiple post-leaching steps and repeated washing in deionised water to ensure consistent control of particles, extractables and ionic residues. The gloves are terminally sterilised by gamma irradiation to a Sterility Assurance Level (SAL) of 10⁻⁶ and are compatible with sterile processing environments due to paperless packaging.

Key Features

– Sterile nitrile cleanroom gloves for high bio-contamination control
– Extra-long design, typical length 600 mm (23.6”)
– Hand-specific fit with textured palms and fingers and a beaded cuff
– Triple DI washed and clean processed
– Terminally sterilised by gamma irradiation to SAL 10⁻⁶
– Low endotoxin level <20 EU/pair
– uniSHIELD™ single-wall technology balancing comfort and protection
– PPE Category III (Complex Design) according to Regulation (EU) 2016/425

Cleanliness and Extractables

– Particle count (≥0.5 µm): <1,200 particles/cm² (typical 1,000 particles/cm²)
– Controlled ionic extractables tested according to IEST-RP-CC005.4
– NVR maximum 10 µg/cm²
– Silicone-free with non-detectable levels of amide and DOP

Sterility and Endotoxins

– Sterility achieved by terminal gamma irradiation to SAL 10⁻⁶ (ISO 11137-2)
– Endotoxin level <20 EU/pair verified by LAL kinetic chromogenic testing (EN 455-3)

Protection Performance

– Protection against micro-organisms tested according to ISO 374-2
– Virus protection tested according to ISO 374-5 and ISO 16604:2004 Procedure B
– Chemical protection performance Type B (KPT) according to ISO 374-1
– Chemical degradation tested according to ISO 374-4

Physical Properties

– Finger thickness 0.20 mm (7.9 mil)
– Palm thickness 0.17 mm (6.7 mil)
– Cuff thickness 0.11 mm (4.3 mil)
– Typical length 600 mm
– Acceptable Quality Level (AQL) <0.65

Standards and Certifications

– PPE Category III according to Regulation (EU) 2016/425
– CE 2797 and UKCA 0086 certified
– ISO 21420, ISO 374-1 Type B, ISO 374-2, ISO 374-4 and ISO 374-5
– EN 16523-1 and ISO 16604 Procedure B
– EN 455-1, EN 455-2, EN 455-3 and EN 455-4
– ISO 11137-2 and ISO 10993-10
– Manufactured under ISO 9001, ISO 13485 and ISO 14001 quality systems

Applications

– Sterile cleanroom and aseptic processing environments
– Pharmaceutical and biotechnology manufacturing
– Critical operations requiring extended glove coverage and validated sterility

View the technical data sheet by clicking HERE