Datasheet

RND is a trademark of Distrelec
Dermagrip Nitrile Extended
Cuff Protection Gloves,
Powder Free, Non Sterile
RND 600-00251
Features
Dermagrip Powder Free Nitrile Gloves, provide an alternative solution for individuals who are allergic to
natural rubber latex
Formulated with 100% Nitrile (Acrylonitrile-butadiene), the nitrile gloves do not contain natural latex
protein and do not exhibit any chemical residue level when tested with HPLC using water extraction
method
The gloves are biocompatibility friendly in addition to providing the usual barrier protection property
needed for examination gloves
Specifications
DESIGN AND FEATURE
Ambidextrous, textured surface of fingers (E4) and beaded cuff
TYPE
Powder free, extended cuff and non-sterile disposable protection
gloves
MATERIAL
100% nitrile (Acrylonitrile-butadiene)
COLOR
Blue (PMS 285)
SURFACE TREATME NT
Chlorination
POWDER FREE RESIDUE (mg/glove)
0.6
DIMENSION - PALM WIDTH (MM)
Small : 80 ± 10
DIMENSION - LENGTH (MM)
Small : min. 290
SINGLE-WALL
THICKNESS (MM)
FINGER
PALM
CUFF
0.17 ± 0.03
Min. 0.08
Min. 0.08
PHYSICAL
PROPERTIES
TENSILE STRENGTH (MPA )
ELONGATION (%)
MODULUS 500% (MPA )
FORCE AT BREAK (N)
(Before Aging) : min. 14
: min. 500
NA
: min. 9
(After Aging) : min. 14
: min. 400
NA
: min. 6
GLOVE MARKING
No Marking
LOT NUMBER IDENTIFICATION ON FINISHED GOODS
Lot Number Structure: YMMPPPPSS
Y = Year of Packing P = WRP’s PWO
MM = Month of Packing SS = Size
PRODUCT SHELF LIFE
5 years upon manufactured date
PRE-SHIPMENT
INSPECTION
N=13 (EN455-2); S-2, AQL 4.0 (ASTM
D6319) N=13 (EN455-2); S-2, AQL 4.0
(ASTM D6319) G-I, AQL 1.5
N=5
G-I, AQL 2.5
G-I, AQL 4.0
DIMENSION
PHYSICAL PROPERTIES
100 ML WATER LEAK
POWDER FREE RESIDUE
MAJOR VISUAL INSPECTION
MINOR VISUAL INSPECTION
PRODUCT CONFORMANCE
Medical Device: in compliance with European Medical
Device Directive 93/42/EEC (CE Class I)
EN455 Parts 1, 2, 3 and 4
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
ASTM D6319
QUALITY ASSURANCE
US FDA Quality System Regulation (QSR)
BS EN ISO9001
BS EN ISO13485 Quality Systems
Quantity - 100 gloves

Summary of content (4 pages)