COMFIT®

Premium Powdered Latex, Sterile

C30xx-05
Superior Quality

COMFIT® Premium Surgical Gloves are designed to meet and surpass the requirements of all international standards for powdered surgical gloves. The gloves are formulated with high quality natural rubber latex which ensures high tensile strength is achieved. Manufactured with an anatomically correct ergonomic design, COMFIT® Premium Surgical Gloves offer superior dexterity with enhanced comfort and flexibility. With features such as a reinforced cuff, size printing and low protein levels, COMFIT® Premium Surgical Gloves will meet the needs of today’s healthcare professionals. Read More

Premium Powdered Latex, Sterile Special

Type Lightly powdered and Gamma-sterilized surgical gloves
Primary Materials Natural rubber latex
Powder USA FDA approved USP absorbable cornstarch
Color Natural (i.e. off-white to yellow)
Design and Feature Hand Specific, anatomically curved fingers, skin grip surface finish and beaded cuff.
Packing 1 pair (1 left and 1 right) of gloves per inner wrap, 1 inner wrap per pouch, 50 pouches per dispensers, 6 dispensers per carton
Product Conformance
  • Personal Protective Equipment of Complex Design Category III, in compliance with 89/686/EEC, type tested to EN 420:2003+A1:2009, EN 374-2:2003, EN 374-3:2003 & EN 388:2003 CE0086
  • Medical Device, in compliance with 93/42/EEC, type tested to EN 455-1:2000, EN 455-2:2015, EN 455-3:2015, EN 455-4:2009 and ASTM D3577, CE0086 Class Ila Sterile
Quality Assurance
  • US FDA Quality System Regulation (QSR)
  • ISO90001 Quality Mangement System
  • BS EN ISO13485 Quality Systems

  • Store in cool dry place
    Store in cool dry place
  • Do not expose to water
    Do not expose to water
  • Single use only
    Single use only

Pre-shipment Quality Inspection

Criteria Inspection Sampling Plan
Dimension N=13, Median
Physical Properties N=13, Median
1000ml Water Leak Test G-I, AQL 0.65
Protein Content N=8
Powder Free Residue N=2
Visual Inspection for Major Defects G-I, AQL 1.5
Visual Inspection for Minor Defects G-I, AQL 4.0

Physical Properties

*Typical Physical Properties Before Aging After Aging
Tensile Strength (MPa) 30 21
Elongation (%) 860 820
Modulus 500% (MPa) 4.0 2.7
Force At Break (N) 18 17

Dimension

Glove Size Reorder# Palm Width (mm) Length (mm)
5 ½ C3055-05 72 ± 4 270 min
6 C3060-05 77 ± 5 275 min
6 ½ C3065-05 83 ± 5 275 min
7 C3070-05 89 ± 5 280 min
7 ½ C3075-05 95 ± 5 285 min
8 C3080-05 102 ± 6 285 min
8 ½ C3085-05 108 ± 6 285 min
9 C3090-05 114 ± 6 285 min

Thickness

Location of Thickness Measurements Single Wall (mm)
Finger (at 15mm from the extreme tip) 0.22 ± 0.02
Palm (at center of palm) 0.20 ± 0.02
Cuff (at 25mm from cuff end) 0.19 ± 0.02