PROFEEL®

DHD Double Gloving System Latex, Sterile

P33xx-61
Exceptional Protection
  • Two pairs of gloves per pack: overgloves and undergloves
  • Wearing two pairs of surgical gloves provide an additional barrier and further reduce the risk of contamination.
  • Reduce the number of perforation to innermost pair of surgical gloves.
  • Natural Rubber Latex’s intrinsic softness provides an exceptionally comfortable and exible glove.
  • Damp Hand Donning (DHD™) – Inner surface of the glove is coated with a proprietary polymer to enhance damp hand donning.
  • A non slick skin-grip surface nish provides excellent instrument grip, under both wet and dry conditions.
  • A superior tactile sensitivity provides optimum ‘feel’.
  • Specially designed high tack band near the cu of the glove to securely hold onto the wearer’s gown to minimize roll down.
  • A reinforced beaded cu feature ensures easy donning while preventing tearing.
  • Tested for water leak before packing to AQL 0.65.
  • The cu is printed with size and logo for easy identication.
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DHD Double Gloving System Latex, Sterile Special

Overglove  
Type Powder free, polymer coated, damp-hand-donnable (DHDTM) and Gamma-sterilized surgical gloves
Primary Materials Natural rubber latex
Color Off white
Design and Feature Hand Specific, curved fingers, bisque finish (SH3) and beaded cuff
Surface Treatment Polymer coating on inner surface to ease donning
Underglove  
Type Micro thin, powder free, polymer coated, damp-hand-donnable (DHDTM) and Gamma-sterilized surgical gloves
Primary Materials Natural rubber latex
Color Green (PMS 3275U)
Design and Feature Hand Specific, curved fingers, smooth finish for easy double gloving and beaded cuff
Surface Treatment Polymer coated on inner surface to ease donning. Outer surface is smooth
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, Median 
Physical Properties N=13, Median
1000ml Water Leak Test G-1, AQL 0.65
Visual Inspection for Major Defects G1, AQL 1.5
Visual Inspection for Minor Defects G1, AQL 4.0

Physical Properties

*Typical Physical Properties Overglove Underglove
Before Aging After Aging Before Aging After Aging
Tensile Strength (MPa) Min. 24 Min. 18 Min. 24 Min. 18
Force At Break (N) Min. 12 Min. 9 Min. 9 Min. 9

Dimensions (Overglove & Underglove)

Glove Size Reorder# Palm Width (mm) Length (mm)
5 ½ P3355-61 72 ± 4 278 min
6 P3360-61 77 ± 5 280 min
6 ½ P3365-61 83 ± 5 280 min
7 P3370-61 89 ± 5 283 min
7 ½ P3375-61 95 ± 5 287 min
8 P3380-61 102 ± 6 288 min
8 ½ P3385-61 108 ± 6 290 min

Thickness

Location of Thickness Measurements Overglove Underglove
Fingers 0.21 ± 0.02 0.18 ± 0.03
Palm 0.17 ± 0.02 min. 0.10
Cuff 0.16 ± 0.02 min. 0.10