Sterilized in a validated process cycle to achieve sterility assurance level of 10-6, and air wash cycles to reduce sterilant residue to less than 4mg/unit.
Chemical residue almost nil, eliminates risk of Contact Dermatitis - Type IV Allergy.
Lightly powdered with Modified Bio-Absorbable Corn starch to prevent wound infections and granulomas.
The protein content is less than 200µg/dm2 to reduce the risk of user being sensitized to Latex Protein Allergy Type 1.
Manufactured in a clean environment to achieve low bio burden level prior to sterilization. This achieves low Pyrogen level after sterilization.
Manufactured in a clean environment to comply with EN 556 & ISO 13485 requirements.
ASTM : D-3577-2009 & EN 455-1:2000, EN 455-2:2015 & EN 455-3:2015, ISO 10282:2014 & IS 13422.
Registered with US FDA (510K).
CE Mark - MDD Class IIa / PPE Cat. III.
Passes viral penetration test - ASTM F 1671:2007.
AQL 1.5 for pin holes.