EPIC®

MT Latex Powder Free, Sterile

EP-12-xx
Micro Textured Grip
  • Powder-free to provide freedon from powder induced allergies, adhesions and granulomas in addition to eliminating the need to wash or wipe gloves before a surgical procedure.
  • A synthetic polymer inner coating makes for easy donning
  • A non-slick micro-textured surface finish provides excellent instrument grip, under both wet and dry conditions.
  • A superior tactile sensitivity provides optimum 'feel'.
  • Specially designed to minimize roll down.

MT 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 Natural Transclucent
Design and Feature Hand secific, Anatomically curved fingers, Palm and fingers Micro Textured, Skin grip 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 Regulations (QSR)
  • ISO90001 Quality Mangement System
  • BS EN ISO13485 Quality Management Systems

  • Store in cool dry place
    Store in cool dry place
  • Latex free
    Latex free
  • Single use only
    Single use only

Physical Properties

*Typical Physical Properties Before Aging After Aging
Tensile Strength (MPa) 28 26
Force At Break (N) 19 16

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-12-55 72 ± 4 278 min.
6.0 EP-12-60 77 ± 5 280 min
6.5 EP-12-65 83 ± 5 280 min
7.0 EP-12-70 89 ± 5 283 min
7.5 EP-12-75 95 ± 5 287 min
8.0 EP-12-80 102 ± 6 288 min
8.5 EP-12-85 108 ± 6 290 min
9.0 EP-12-90 114 ± 6 290 min

Thickness

Location of Thickness Measurements Single Wall (mm)
Fingers (at 15mm from the extreme tip) 0.22 ± 0.03
Palm (at center of palm) 0.18 ± 0.03
Cuff (at 25mm from cuff end) 0.15 ± 0.02