DERMAGRIP®

SAFEDON Latex Powder Free

D15xx-50
A Vital Part of Your Infection Control System

Medical gloves serve to provide protection from unwanted and dangerous substances for both healthcare professional and their patients. DERMAGRIP® Examination Gloves are designed to meet and exceed international product standards using sophisticated technologies and innovations to provide uncompromized protection to its users. DERMAGRIP® Examination Gloves stand out for its unique surface texture allowing for extra sensitivity. This is the preferred glove whenever extra sensitivity and special surface texture is important.

SafeDon System

Hospital-acquired infections (HAI’s) are a growing concern in today’s healthcare environment1. The most common route of contamination is through hands. 2,3 Despite the introduction of hand washing initiatives the level of compliance cannot be guaranteed to reach 100%.3 Interna-tional studies have shown that gloves and traditional glove boxes themselves can be a vehicle for contamination.4,5 The new innovative SafeDonTM dispensing system is a hygienic initiative which further helps to reduce the risk of cross contamination.

The Gloves Most Critical Surfaces-Thumb, Fingers and Palm-Are Never Touched

SafeDonTM TM TM dispensing mechanism ensures that the user does not touch the gloves within the box or the box itself whilst removing gloves. This unique design helps to reduce contamination and reduce risk of cross infections.6,7 With appropriate use of gloves and adherence to hand hygiene policies the new SafeDonTM dispensing system will help to further improve infection control.

SAFEDON Latex Powder Free Special

Type Powder free and non-sterile
Primary Materials Natural rubber latex
Powder No powder lubricant added. Light chlorinated on glove surface
Protein Content This latex glove contains 50 micrograms or less of total water extractable protein per gram of glove
Color Off white to yellow
Design and Feature Ambidextrous, textured surface overall and beaded cuff
Packing 100 gloves per dispenser, 10 dispensers per carton
Product Conformance
  • Medical Device: in compliance with European Medical Device Directive 93/42/EEC (CE Class I)
  • EN 455-1(2000), EN 455-2(2009 + A1: 2015), EN 455-3(2015), and EN 455-4(2009)
  • ASTM D3578
  • 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, CE 0086
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, AQL Median
Physical Properties N=13, AQL Median
1000ml Water Leak Test G-I, AQL 1.5
Visual Inspection for Major Defects G-I, AQL 2.5
Visual Inspection for Minor Defects G-I, AQL 4.0
Powder Free Residue N=5, AQL N/A
Protein Contain N=8, AQL N/A

Physical Properties

*Typical Physical Properties Before Aging After Aging
Tensile Strength (MPa) ≥ 21 ≥ 18
Force At Break (N) ≥ 9 ≥ 6

Dimensions

Glove Size Reorder# Palm Width (mm) Length (mm)
Extra-SmallD1500-50 ≤ 80 240 min
SmallD1501-50 80 ± 10 240 min
MediumD1502-50 95 ± 10240 min
LargeD1503-50 110 ± 10240 min
Extra-largeD1504-50≥ 110240 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) 0.13 ± 0.02
Cuff (at 25mm from cuff end) 0.10 ± 0.01