SHIELDskin XTREME™ Natural Sterile Latex 300 DI Cleanroom Gloves – 300 mm, PPE Category III

SHIELDskin XTREME™ Sterile Latex 300 DI are sterile natural rubber latex cleanroom gloves designed for bio contamination control in controlled and sterile processing environments. The gloves are hand-specific, powder-free and single DI washed, supporting high levels of fit, dexterity and contamination control in cleanroom operations.

The gloves are clean processed with multiple post-leaching steps and washing in deionised water to control particles and extractables. They are terminally sterilised by gamma irradiation to a Sterility Assurance Level (SAL) of 10⁻⁶, with low endotoxin content demonstrated at <20 EU/pair. The design includes textured fingers and palms with a beaded cuff, supporting secure handling and reliable donning.

Key Features

– Sterile natural rubber latex cleanroom gloves for bio contamination control
– Standard length 300 mm (11.8”)
– Hand-specific design with textured palm and fingers and a beaded cuff
– Powder-free, single DI washed and clean processed
– Terminally sterilised by gamma irradiation to SAL 10⁻⁶
– Low endotoxin level <20 EU/pair
– uniSHIELD™ single-wall technology for balanced comfort and protection
– PPE Category III (Complex Design) according to Regulation (EU) 2016/425

Cleanliness and Extractables

– Particle count (≥0.5 µm): <3,000 particles/cm² (typical 1,100 particles/cm²)
– Controlled ionic extractables tested according to IEST-RP-CC005.4
– NVR maximum 25 µg/cm²
– Silicone-free with non-detectable amide and DOP levels

Sterility and Endotoxins

– Sterility: terminal gamma irradiation to SAL 10⁻⁶ (ISO 11137-2:2015)
– Endotoxins: <20 EU/pair (EN 455-3:2015)

Protection Performance

– Tested against micro-organisms 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 0.18 mm (7.1 mil)
– Cuff thickness 0.12 mm (4.7 mil)
– Typical length 300 mm
– AQL <0.65

Allergy and Biocompatibility

– Biocompatibility demonstrated by skin irritation and sensitisation testing according to ISO 10993-10:2021
– Accelerators: free of thiazoles and thiurams
– Latex protein: ≤50 µg/g (typical ≤30 µg/g) per EN 455-3:2015 / ASTM D5712-15

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 processing environments and cleanrooms
– Pharmaceutical, biotechnology and laboratory operations requiring sterile gloves
– Controlled tasks requiring low endotoxins and validated sterility assurance

View the technical data sheet by clicking HERE