COMFIT®

Powdered

C10xx-01
Superior Quality

Medical examination gloves serve to provide protection from unwanted or potentially dangerous substances for both healthcare professionals and patients. With the increasing needs for uncompromised protection and demand for high quality gloves, COMFIT® Examination Gloves are your prime choice.

Formulated with the best quality natural rubber latex to meet both local and international standards for medical gloves, COMFIT® Examination Gloves are designed to provide maximum protection while still being is economically affordable. Read More

Powdered Special

Type Powdered and non-sterile
Primary Materials Natural rubber latex
Powder FDA approved USP absorbable cornstarch
Color Off white
Design and Feature Ambidextrous, smooth and beaded cuff
Packing 100 gloves per dispenser, 10 dispensers per carton
Product Conformance
  • Conform to ASTM D3578, ASTM D6124, ASTM D5712 and ASTM D5151
  • Personal Protective Equipment of Complex Design category III, in compliance with 89/686/EEC, type tested to EN 420:2003+Al:2009, EN 374-2:2003, EN 374-3:2003 & EN 388:2003, CE 0086; Class1.
  • Medical Device, in compliance with 93/42/EEC, type tested to EN455-1:2000, EN 455-2:(2009+A1:2015), EN 455-3:2015, EN 455-4:2009 and ASTM D3578, CE 0086
Quality Assurance
  • US FDA Quality System Regulations (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 S-2, AQL 4.0
Physical Properties S-2, AQL 4.0
1000ml Water Leak Test G-1, AQL 1.5
Visual Inspection for Major Defects G-1, AQL 2.5
Visual Inspection for Minor Defects G-1, AQL 4.0

Physical Properties

Parameters Before Aging After Aging
Tensile Strength (MPa) min 18 min 14
Elongation (%) min 650 min 500

Dimensions

Glove Size Reorder# Palm Width (mm) Length (mm)
Extra-small C1000-01 76 ± 10 min. 240
Small C1001-01 84 ± 10 min. 240
Medium C1002-01 94 ± 10 min. 240
Large C1003-01 105 ± 10 min. 240
Extra-Large C1004-01 113 ± 10 min. 240

Thickness

Location of Thickness Measurements Single Wall (mm)
Finger (at 15 mm from the extreme tip) 0.15 ± 0.02
Palm (at center of palm) 0.10 ± 0.02
Cuff (at 25 mm from cuff end) N/A

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