Data Sheet - HPC Healthline

Nitrile Examination Gloves
Handsafe GN99
®
Product Type:
Powder Free Nitrile Examination Gloves
Size
Product Code
NHS Code
Small Medium Large X-Large
GN99
GN99
GN99
GN99
FTG025 FTG026 FTG027 FTG140
Gloves Specification:
Material: Nitrile
Surface Finish: Finger textured
Colour: Blue
Design: Ambidextrous. Latex free. Beaded cuff for added
strength and easier donning. Strong, soft and flexible.
Latex Free: Yes
Packing:
Dispenser: 100 gloves per dispenser box
Outer Case: 10 dispensers per case
Pallet: 60 cases per pallet
S
S
S
Performance Specification:
Freedom from holes - BS EN 455-1
General Inspection Level 1, AQL 1.5
Water Tight Test
Dimensions – BS EN 455-2
Palm Width (mm)
Length (mm)
Small
80 +/- 10
240 min
Medium
95 +/- 10
240 min
Large
110 +/- 10
240 min
Force at Break – BS EN 455-2
Throughout shelf life
After challenge test
Minimum 9 Newton
Minimum 9 Newton
Biological Properties – BS EN 455-3
Powder Level
Protein Content (Latex only)
Less than 2 mg per glove
≤50μg/g using the modified Lowry method
X-Large
≥ 110
240 min
Viral Penetration – ASTM F1671-7
Phi-X174 Bacteriophage penetration No visual penetration
Shelf Life Properties – BS EN 455-4
Currently shelf life is determined through accelerated ageing and is set at 3 years (whilst real time
studies are in progress)
Quality Standards:
Manufacturing QMS
Glove
Sampling & Inspection
MDD Requirement
CE Classification
Glove Care
EN ISO 9001 / EN ISO 13485
The BS EN 455 series of standards (parts 1,2,3 and 4)
ISO2859-1
Medical Devices Directive 93/42/EEC (and subsequent amendments)
Class I non-sterile Medical Device
Keep away from direct sunlight or fluorescent light. Store at temperature no
less than 5°C, no more than 25°C
Nitrile Examination Gloves
Handsafe GN99
®
Packaging Artwork:
InnerOuter
COLOUR GUIDE
237mm
240mm
GN99
Blue Nitrile
Examination Gloves - Powder Free
1000 (10x100)
GN99 Blue Nitrile
Examination Gloves - Powder Free
approx. by
weight
S
S
100
Nitril-Untersuchungshandschuhe - blau - Puderfrei
Gants d'examen Nitrile - bleu - Non poudré
Guantes de examen en Nitrilo - azul - Sin polvo
Nitrile onderzoekhandschoenen - blauw - Ongepoederd
Luvas de examen de Nitrilo - azul - Sem pó
Rukavice vyšetřovací Nitrilové - modré - Bez pudru
Nitrylowe rękawice diagnostyczne - niebieskie - Bezpudrowe
approx. by
weight
100
Class 1
Medical
Device
0086
5 024951 014744 >
XSS
GN99
SV
DA
FI
NO
RO
BG
AR
g
H
N
Carton No:
Undersökningshandskar i Nitril - blå - Puderfria
Nitril undersøgelseshandske - blå - Pudderfri
Nitriili tutkimuskäsineet - sininen - Puuteroimaton
Nitrile undersøkelseshansker - blå - Pudderfri
Manusi examinare Nitril - albastru - Fara pudra
Ръкавици медицински стерилни - син - без пудра
‫ ﺑﺪﻭﻥ ﺑﻮﺩﺭﺓ‬- ‫ ﺃﺯﺭﻕ‬- ‫ ﻧﻴﺘﺮﻳﻞ‬- ‫ﻓﺤﺺ ﺍﻟﻘﻔﺎﺯﺍﺕ‬
Handsafe-GN99-2
5 024951 014744 >
MHPCHL, PO Box 85, SM4 9AW, UK
GN99
Blue Nitrile
Examination Gloves - Powder Free
1000 (10x100)
Class 1
Medical
Device
0086
S
Blue Nitrile
Examination Gloves
Powder Free
1000 (10x100)
5 024951 014744 >
g
H
N
Carton No:
Handsafe-GN99-2
MHPCHL, PO Box 85, SM4 9AW, UK
5 024951 014744 >
400mm
S
GN99 Blue Nitrile
Examination Gloves - Powder Free
100
9N
approx. by
weight
100
approx. by
weight
S
S
Manufactured in accordance with Class 1
Medical Devices Directive 93/42/EEC
117mm
COLOUR GUIDE
PANTONE 123U
5 024951 014690 >
100
approx. by
weight
GN99 Blue Nitrile
Examination Gloves
Powder Free
open
here
DE Nitril-Untersuchungshandschuhe - blau - Puderfrei
FR Gants d'examen Nitrile - bleu - Non poudré
ES Guantes de examen en Nitrilo - azul - Sin polvo
NL Nitrile onderzoekhandschoenen - blauw - Ongepoederd
PT Luvas de examen de Nitrilo - azul - Sem pó
CS Rukavice vyšetřovací Nitrilové - modré - Bez pudru
PL Nitrylowe rękawice diagnostyczne - niebieskie - Bezpudrowe
117mm
GN99 Blue Nitrile
Examination Gloves
Powder Free
SV Undersökningshandskar i Nitril - blå - Puderfria
DA Nitril undersøgelseshandske - blå - Pudderfri
FI Nitriili tutkimuskäsineet - sininen - Puuteroimaton
NO Nitrile undersøkelseshansker - blå - Pudderfri
RO Manusi examinare Nitril - albastru - Fara pudra
BG Ръкавици медицински стерилни - син - без пудра
AR ‫ ﺑﺪﻭﻥ ﺑﻮﺩﺭﺓ‬- ‫ ﺃﺯﺭﻕ‬- ‫ ﻧﻴﺘﺮﻳﻞ‬- ‫ﻓﺤﺺ ﺍﻟﻘﻔﺎﺯﺍﺕ‬
5 024951 014690 >
DE
FR
ES
NL
PT
CS
PL
S
Blue Nitrile
Examination Gloves
Powder Free
1000 (10x100)
X SMALL
GN99
247mm
GUIDE
S
X SMALL
Pantone 186 C
78mm
Undersökningshandskar i Nitril - blå - Puderfria
Nitril undersøgelseshandske - blå - Pudderfri
Nitriili tutkimuskäsineet - sininen - Puuteroimaton
Nitrile undersøkelseshansker - blå - Pudderfri
Manusi examinare Nitril - albastru - Fara pudra
Ръкавици медицински стерилни - син - без пудра
‫ ﺑﺪﻭﻥ ﺑﻮﺩﺭﺓ‬- ‫ ﺃﺯﺭﻕ‬- ‫ ﻧﻴﺘﺮﻳﻞ‬- ‫ﻓﺤﺺ ﺍﻟﻘﻔﺎﺯﺍﺕ‬
20% Black (K)
BLACK (K)
SV
DA
FI
NO
RO
BG
AR
PANTONE REFLEX BLUE C
X-Small
Nitril-Untersuchungshandschuhe - blau - Puderfrei
Gants d'examen Nitrile - bleu - Non poudré
Guantes de examen en Nitrilo - azul - Sin polvo
Nitrile onderzoekhandschoenen - blauw - Ongepoederd
Luvas de examen de Nitrilo - azul - Sem pó
Rukavice vyšetřovací Nitrilové - modré - Bez pudru
Nitrylowe rękawice diagnostyczne - niebieskie - Bezpudrowe
Compliant with the Medical Devices Directive 93/42/EEC and European Standard EN455: Medical Gloves for Single Use.
Manufactured to meet EN455 Parts 1, 2, 3 and 4.
Compliant with the Personal Protective Equipment Directive 89/686/EEC and European Standard EN420: Protective
Gloves. Classification CAT III waterproof gloves and low chemical resistance (not reflecting duration of protection).
PPE type examination conducted by British Standards Institute (0086).
Safe for food use - compliant with Regulation (EC) 1935/2004 and Commission Regulation 10/2011 Plastic materials
and articles intended to come into contact with food.
Conforme à la directive médicale 93/42/CEE et la norme européenne EN455: Gants médicaux à usage unique.
Fabriqué selon la norme EN455, parties 1, 2, 3 et 4.
Conforme à la directive EPI 89/686/CEE et la norme européenne EN420: Gants de protection.
Classification CAT III: étanchéité et resistance chimique légère. Certification BSI (0086).
Certifié agroalimentaire - conforme au règlement (CE) 1935/2004 et règlement de la Commission 10/2011 Matières
plastiques et objets destinés à entrer en contact avec les aliments.
Konform mit der Richtlinie 93/42/EWG für Medizinprodukte und der europäischen Norm EN 455 Medizinische
Handschuhe zum einmaligen Gebrauch. Hergestellt gemäß der Normen EN455 Teil 1, 2, 3 und 4.
Konform mit der Richtlinie PSA 89/686/EWG und der Europäischer Norm EN420-Schutzhandschuhe. Kat III Klassifikation:
Penetrationsprüfung und geringer Chemikalien Schutz. BSI Bescheinigung (0086).
Lebensmittelgeprüft - konform mit der Verordnung (EG) 1935/2004 und der Verordnung 10/2011 der Kommission
Kunststoff-Materialien und Gegenstände, die mit Lebensmitteln in Berührung zu kommen.
g
H
N
h GN99 S
XS
GN99
S
GN99
M
GN99
L
GN99
WARNING: Contains ZDBC and ZDEC chemicals, which can cause type IV skin irritation and contact dermatitis.
ATTENTION: Contient les chimiques ZDBC et ZDEC qui peuvent causer des irritations type IV de la peau.
ACHTUNG: Enthält ZDBC und ZDEC Chemikalien, der Typ IV allergische Reaktionen auslösen kann.
0086
EN420
BSI, Milton Keynes, MK5 8PP
Small
Medium
Large
X-Large
Dimensions:
Dispenser: L235mm x W125mm x H70mm
Outer: L360mm X W255mm X H245mm
XL
GN99
For single use only. Keep in a cool dry place, away from direct sunlight or fluorescent light
Pour usage unique seulement. Entreposer dans un endroit frais et sec, à l’abri de la lumière du soleil et de l’éclairage fluorescent
Nur zum einmaligen Gebrauch. Kühl und trocken lagern. Direktes Sonnenlicht und fluoreszierendes Licht vermeiden
M HPCHL, PO Box 85, SM4 9AW, UK.
TRANSPARENCY - DO NOT PRINT AS WHITE
Size Colour coding
GN99 Blue Nitrile
Examination Gloves - Powder Free
DE
FR
ES
NL
PT
CS
PL
BLACK (K)
Penetration:
Level 2
Barcodes:
Size
Small
Medium
Large
X-Large
Inner
5024951014690
5024951014706
5024951014713
5024951014720
Outer
5024951014744
5024951014751
5024951014768
5024951014775
Packaging Symbols:
g
N
H
M
Class I
Medical
Device
Lot number
LATEX
Latex free
Date of manufacture
POWDER
Powder free
Use by
AQL
1.5
Acceptable quality
level
Manufacturer
Compliant with
Protective Gloves
general requirements
Compliant with the
Medical Devices
Directive
Food Approved
Compliant with the
Personal Protective
Equipment Directive
EN374-2:2003
F
EN374 - 3: 2003
d
Non sterile
D
Single use - do not
re-use
GN99/NOV 2013
p
w
5:
l25:
Keep dry
Keep away from
sunlight
Temperature
limitation
Recyclable
packaging
Protection against
micro-organism and
biological hazards
Protection against
chemical hazards
Healthline
Colwood House, 158 Garth
Road, Morden, Surrey,
SM4 4LZ England
020 8335 5213 (Office)
020 8335 5252
[email protected]
www.healthline.co.uk