PROFEEL®

Powder Free Latex Surgical Gloves, Sterile

P31xx-21
Superior Peformance

The approach taken in meeting the heathcare professionals’ increasingly stringent quality requirement is reflected in the outstanding feature of PROFEEL® Powder Free NR Latex Surgical Gloves.

Being powder free, the gloves provide freedom from powder induced allergies, adhesions and granulomas in addition to eliminate the need to wash or wipe gloves before a surgical procedure. Our proprietary manufacturing process ensures that the gloves contain the lowest level of allowance NR latex protein claim thereby minimizes potential skin allergic reaction related to Type I sensitivities. The gloves are further characterized by low or undetectable level of chemical residue which reduces the risk of irritant or allergic contact dermatitis (Type IV allergic reactions). Read More

Powder Free, Sterile Special

Type Powder free, chlorinated and Gamma Sterile
Primary Materials Natural rubber latex
Powder Chlorinated
Color Natural rubber latex
Design and Feature Hand Specific, straight fingers (SBS), textured surface on palm and fingers provides excellent instruments grip. Superior tactile sensitivy provides optimum ‘feel’ to surgeon. Intrinsic softness allow superior comfort and a natural fit.
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 455-2(2015), EN 455-3(2015), EN 455- 4(2009) and ASTM D3577, CE0086 Class IIa Sterile
Quality Assurance
  • US FDA Quality System Regulations (QSR)
  • ISO90001 Quality Mangement System
  • BS EN ISO13485 Quality Management 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
Physical Properties N=13
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

Physical Properties

*Typical Physical Properties Before Aging After Aging
Tensile Strength (MPa) 28 23
Force At Break (N) 20 19

Dimensions

Glove Size Reorder# Palm Width (mm) Length (mm)
5.5 P3155-21 72 ± 4 278 min
6 P3160-21 77 ± 5 280 min
6.5 P3165-21 83 ± 5 280 min
7 P3170-21 89 ± 5 283 min
7.5 P3175-21 95 ± 5 287 min
8.0 P3180-21 102 ± 6 288 min
8.5 P3185-21 108 ± 6 290 min
9.0 P3390-35 114 ± 6 290 min

Thickness

Location of Thickness Measurements Single Wall (mm)
Fingers (at 15mm from the extreme tip) 0.28 ± 0.02
Palm (at center of palm) 0.24 ± 0.02
Cuff (at 25mm from cuff end) 0.19 ± 0.02