Certified: ISO 13485, CE Mark - Medical device Class IIa / PPE Cat. III, US FDA (510K)
Description
Surgicare®Prepowdered gloves is made from Natural Rubber Latex. The glove is anatomically shaped with thumb ball effect, reducing hand fatigue during surgical procedures. The precision design fit and micro rough surface provides optimum comfort and better instrument grip without compromising on sensitivity. Surgicare Prepowdered gloves provides excellent barrier protection for both doctor and patient.
Safety Features
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.
Other Features
Excellent Donning and Fit
Certificates
ISO 13485
CE Mark - Medical device Class IIa / PPE Cat. III
US FDA (510K)
EN 556
ASTM D 3577-19 (2023)
EN 455-1:2020+A2:2024
EN 455-2:2024
EN 455-3: 2023
ISO 10282:2023
IS 13422:2024
ASTM F 1671:2022
PPE Standards EN 374
EN 420
CE Certified
ISO 13485
CE Mark-Medical device Class IIa
ASTM F 1671:2013
ISO 13485
EN 556
US FDA (510K)
CE Mark-Medical device Class IIa/PPE Cat. Ill
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