Certified: ISO 13485, CE Mark - Medical device Class IIa / PPE Cat. III, US FDA (510K)
Description
Surgicare® Powder free is made from Natural Rubber Latex. The powderfree gloves, eliminates all risks associated with powder. The glove is anatomically shaped with thumb ball effect, reducing hand fatigue during surgical procedures. Surgicare provides excellent barrier protection for both doctor and patient.
Safety Features
Latex protein no more than 50μg of protein per gram and dm², eliminates risk of Latex Allergy - Type 1.
Chemical residue almost nil, eliminates risk of Contact Dermatitis - Type IV Allergy.
Absence of powder eliminates dangers associated with powder, preventing granulomas, adhesions, fibrosis and occupational asthma. Does not contaminate sterile work area.
Latex film structure passes Viral Penetration Test (ASTM F1671:2013)
Manufactured in clean environment to reduce 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.
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.
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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