EPIC®

Pro Powdered Latex, Sterile

EPPRO-14-xx
 

 

Pro Powdered Latex, Sterile Special

Type Lightly powdered and Gamma-sterilized
Primary Materials Natural rubber latex
Surface Treatment Powdered with FDA approved USP absorbable cornstarch
Powder Max. 15
Protein Content Recommended limit ≤ 200
Color Natural
Design and Feature Hand Specific, curved fingers, bisque finish and 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 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) min. 24 min. 18
Force At Break (N) min. 9 min. 9

Pre-shipment Quality Inspection:

Criteria 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

Dimensions

Glove Size Reorder# Palm Width (mm) Length (mm)
5.5 EPPRO 14-55 72 ± 4 250 min.
6.0 EPPRO 14-60 77 ± 5 260 min
6.5 EPPRO 14-65 83 ± 5 265 min
7.0 EPPRO 14-70 89 ± 5 270 min
7.5 EPPRO 14-75 95 ± 5 270 min
8.0 EPPRO 14-80 102 ± 6 270 min
8.5 EPPRO 14-85 108 ± 6 280 min
9.0 EPPRO 14-90 114 ± 6 280 min

Thickness

Location of Thickness Measurements Single Wall (mm)
Fingers (at 15mm from the extreme tip) 0.17 ± 0.02
Palm (at center of palm) 0.13 ± 0.02
Cuff (at 25mm from cuff end) 0.13 ± 0.02