EPIC®

N Nitrile Powder Free, Sterile

EP-13-xx
Surgical Non-Latex Gloves
  • Powder-free to provide freedom from powder induced allergies, adhensions and granulomas in addition to eliminating the need to wash or wipe gloves before a surgical procedure.
  • Does not contain any Natural Rubber Latex benifiting individuals with type I Natural Rubber Protein Allergies.
  • A superior tactile sensitivity provide optimum 'feel'.
  • Specially designed to miminize roll down.

N Nitrile Powder Free, Sterile Special

Type Powder free, Non-Latex and Gamma Sterilized
Primary Materials Nitrile (latex-free)
Powder < 2
Color White
Design and Feature Hand Specific, curved fingers, bisque finish and beaded cuff
Packing 1 pair of gloves per inner wrap, 1 inner wrap per pouch, 50 pouches 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 455-2:2009, EN 455-3:2006, 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
  • Latex free
    Latex free
  • Single use only
    Single use only

Physical Properties

*Typical Physical Properties Before Aging After Aging
Tensile Strength (MPa) min. 26 min. 9
Force At Break (N) min. 9 min. 9

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
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 EP-13-55 72 ± 4 278 min.
6.0 EP-13-60 77 ± 5 280 min
6.5 EP-13-65 83 ± 5 280 min
7.0 EP-13-70 89 ± 5 283 min
7.5 EP-13-75 95 ± 5 287 min
8.0 EP-13-80 102 ± 6 288 min
8.5 EP-13-85 108 ± 6 290 min
9.0 EP-13-90 114 ± 6 290 min

Thickness

Location of Thickness Measurements Single Wall (mm)
Fingers (at 15mm from the extreme tip) 0.16 ± 0.02
Palm (at center of palm) 0.15 ± 0.02
Cuff (at 25mm from cuff end) 0.13 ± 0.02