Certified: ISO 13485, CE Mark - Medical device Class IIa / PPE Cat. III, US FDA (510K)
Description
Kaltex Powdered 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. Kaltex Powdered 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 5 ppm
Chemical residue almost nil, eliminates risk of Contact Dermatitis-Type IV Allergy. Powdered with Modified Bio-Absorbable Corn starch USP Grade, to prevent wound infections and granulomas.
Manufactured in clean environment to achieve bio burden level of less than 20 cfu prior to sterilization. This achieves low Pyrogen level (dead bacteria) after sterilization.
Manufactured in a clean environment to comply with EN 556 & ISO 13485 requirements.
Other Features
Excellent Donning and Fit
Special Features of Our Former
Egronomically designed to produce gloves of high comfort.
Designed to mimic the shape of the relaxed hand.
Anatomically designed.
Curved Fingers follow the natural fingers shape at rest to reduce fatigue and increase finger dexterity even during rigorous procedures.
Minimizes resistance in forming the normal working hand postures.
Projected thumb ball to reduce stress on Thumb
Reduces upto 20% less effort to form a closed hand.
Less stress on glove/hand especially over extended period of use, and enables long wearability.
The multi-contoured palm and fingers ensure comfort for precision surger
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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