DERMAGRIP®

SAFEDON Nitrile Ultra LT Powder Free

D15xx-80
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 LT Examination Gloves meet and exceed international product standards to provide uncompromising protection to its users. Dermagrip® Nitrile Ultra LT Examination Gloves are formulated with 100% nitrile (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 environments. 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•S 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 gloves are dispensed individually Cuff 1 stmi from the box. The Cuff 1strm 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 infectionsP With appropriate use of gloves and adherence to hand hygiene policies the new SafeDonTM dispensing system will help to further improve infection control. Read More

SAFEDON Nitrile Ultra LT Powder Free Special

Type Powder-free and non-sterile
Primary Materials Acrylonitrile-butadiene
Powder No powder lubricant added
Color Blue (PMS 292 U)
Design and Feature Ambidextrous, textured surface at fingers and beaded cuff
Packing 250 gloves per dispenser, 8 dispensers per carton (XS to L) and 240 gloves per dispenser, 8 dispensers per carton (XL)
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)
  • 1509001 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 D1500-80 ≤ 80 min. 240
Small D1501-80 80 ± 10 min. 240
Medium D1502-80 95 ± 10 min. 240
Large D1503-80 110 ± 10 min. 240
Extra-large D1504-80 ≥ 110 min. 240

Thickness

Location of Thickness Measurements Single Wall (mm)
Fingers (at 15mm from the extreme tip) min. 0.07
Palm (at center of palm) min. 0.06
Cuff (at 25mm from cuff end) min. 0.05