DERMAGRIP®

SAFEDON Nitrile Ultra Powder Free

D15xx-79
A Vital Part of Your Infection Control System

Medical gloves provide protection from unwanted and dangerous substances for both healthcare professionals and patients. DERMAGRIP® Nitrile Ultra Examination Gloves meet and exceed international product standards to provide uncompromising protection to its users. Dermagrip® Nitrile Ultra Examination Gloves are formulated with 100% nitrite (Acrylonitrile-butadiene) providing an alternative solution for individuals who are allergic to natural rubber latex.

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 45 The new innovative SafeDonel 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 gloves are dispensed individually Cuff lstim from the box. The Cuff lstn, 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 SafeDonn4 dispensing system will help to further improve infection control. Read More

SAFEDON Nitrile Ultra Powder Free Special

Type Powder-free and non-sterile
Primary Materials Acrylonitrile-butadiene
Powder No powder lubricant added
Color Blue (PMS 285)
Design and Feature Ambidextrous, textured surface at fingers and beaded cuff
Packing 200 gloves per dispenser, 8 dispensers per carton for size X-Small to X-Large
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)
  • Personal Protective Equipment of Complex Design Category III, in compliance with 89/686/EEC, type tested to EN 420:2003+A1:2009, EN 374-12003, EN 374-3:2003 .N 388:2003, CE 0086
  • ASTM D6319
Quality Assurance
  • US FDA Quality System Regulation (QSR)
  • IS09001 Quality Management System
  • IS013485 Quality Management System

  • 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

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
Powder Free Residue N=5
Visual Inspection for Major Defects G-I, AQL 2.5
Visual Inspection for Minor Defects G-I, AQL 4.0

Physical Properties

*Typical Physical Properties Before Aging After Aging
Tensile Strength (MPa) min. 14 min. 14
Force At Break (N) min. 6 min. 6

Dimensions

Glove Size Reorder# Palm Width (mm) Length (mm)
Extra-Small D1500-79 ≤ 80 240 min.
Small D1501-79 80 ± 10 240 min.
Medium D1502-79 95 ± 10 240 min.
Large D1503-79 110 ± 10 240 min.
Extra-large D1504-79 ≥ 110 240 min.

Thickness

Location of Thickness Measurements Single Wall (mm)
Fingers (at 15mm from the extreme tip)0.09 min.
Palm (at center of palm)0.06 min.
Cuff (at 25mm from cuff end)0.05 min.