EPIC®

Latex Powder Free, Sterile

EP-01-xx
 
  • A non-slick skin-grip surface finish provides excellent instrument grip, under both wet and dry condition.
  •  A superior tactile sensitivity provides optimum 'feel'
  • Specially designed high tack band near the cuff of the glove to securely hold onto the wearer's gown to minimize roll down.
  • A reinforced beaded cuff feature ensures easy donning while preventing tearing.

Latex Powder Free, Sterile Special

Type Powder free, polymer coated and gamma sterilized.
Primary Materials Natural rubber latex
Powder Polymer coating online and offline (DHDTM)
Color Off white
Design and Feature Hand Specific, anatomically curved fingers, bisque finish and reinforced beaded cuff.
Packing 1 pair (1 left and 1 right) of gloves per inner wrap, 1 inner wrap per pouch, 50 pouches per dispensers, 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 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) min. 24 min. 18
Force At Break (N) min. 12 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
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 EP-01-55 72 ± 4 278 min.
6.0 EP-01-60 77 ± 5 280 min
6.5 EP-01-65 83 ± 5 280 min
7.0 EP-01-70 89 ± 5 283 min
7.5 EP-01-75 95 ± 5 287 min
8.0 EP-01-80 102 ± 6 288 min
8.5 EP-01-85 108 ± 6 290 min
9.0 EP-01-90 114 ± 6 290 min

Thickness

Location of Thickness Measurements Single Wall (mm)
Fingers (at 15mm from the extreme tip) 0.21 ± 0.03
Palm (at center of palm) 0.17± 0.03
Cuff (at 25mm from cuff end) 0.15± 0.02