PROFEEL®

Lightly Powdered, Sterile

P30xx-20
Exceptional Dexterity
Our innovative approach taken in meeting the healthcare professionals' increasingly stringent quality requirements is reflected in the outstanding features of Profeel Lightly Powdered NR Latex Surgical Gloves.

Manufactured using specially designed porcelain formers, Profeel Lightly Powdered NR Latex Surgical Gloves provide exceptional dexterity to enhance comfort and flexibility. Our proprietary manufacturing process ensure that the extractable NR latex protein content is kept to the minimum thereby reducing allergic skin reactions. In additional, the gloves contain a moderate level of dusting powder which facilitates swift removal of powder prior to surgical procedures.

Lightly Powdered, Sterile Special

Type Powdered and Gamma Sterilized Surgical Gloves
Primary Materials Natural rubber latex
Surface Treatment: Light powdering usind FDA approved USP absorable cornstarch
Powder < 200
Color Natural (i.e: off-white)
Design and Feature Hand specific, anatomically curved fingerd, microroughed surface finish and beaded cuff (SH3)
Packing 1 pairs (1 left and 1 right) gloves per inner wrapper.
1 inner wrapper per pouch, 50 pairs of gloves per dispenser,
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 4552:2015, EN 455-3:2015, EN 455 4:2009 and ASTM D3577, CE0086 Class IIa 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

Physical Properties

*Typical Physical Properties Before Aging After Aging
Tensile Strength (MPa) 28 22
Elongation (%) 860 820
Modulus 500% (MPa) 4 2.8
Force At Break (N) 18 16

Pre-shipment Quality Inspection:

Criteria Sampling Plan
Dimension N=13, Median
Physical Properties N=13, Median
1000ml Water Leak Test G-1, AQL 0.65
Protein Content N=8
Powder Free Residue N=5
Visual Inspection for Major Defects G1, AQL 1.5
Visual Inspection for Minor Defects G1, AQL 4.0

Dimensions

Glove Size Reorder# Palm Width (mm) Length (mm)
5.5 P3055-20 72 ± 4 278 min.
6.0 P3060-20 77 ± 5 280 min
6.5 P3065-20 83 ± 5 280 min
7.0 P3070-20 89 ± 5 283 min
7.5 P3075-20 95 ± 5 287 min
8.0 P3080-20 102 ± 6 288 min
8.5 P3085-20 108 ± 6 290 min
9.0 P3090-20 114 ± 6 290 min

Thickness

Location of Thickness Measurements Single Wall (mm)
Fingers (at 15mm from the extreme tip) 0.22 ± 0.03
Palm (at center of palm) 0.19 ± 0.02
Cuff (at 25mm from cuff end) 0.16 ± 0.02