GS77
Sterile Latex Surgical Gloves
Healthline
Powder Free Latex Surgical Gloves, Sterile
Gloves Specification:
• Rubber latex
• Micro roughened unique surface finish
• Natural
• Excellent instrument grip under both wet and dry conditions
• Low modulus latex compound reducing hand fatigue
and providing added comfort
• Graduated thickness for fingertip sensitivity
• Sterile
• Soft and pliable
• Hand specific
Packing:
Pouch: 1 pair per pouch
Dispenser: 50 pairs per dispenser box
Outer Case: 4 dispensers per case
Pallet: 35 cases per pallet
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)
5.5
72 ± 4
≥ 250
6
77 ± 5
≥ 260
6.5
89 ± 5
≥ 260
7
89 ± 5
≥ 270
7.5
95 ± 5
≥ 270
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
8
102 ± 5
≥ 270
8.5
108 ± 6
≥ 280
9
114 ± 6
≥ 280
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)
Sterilisation Method – BS EN ISO 11137
Gamma Irradiation
Sterilisation
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 IIa Sterile Medical Device
Keep away from direct sunlight or fluorescent light. Store at temperature no
less than 5°C, no more than 25°C
Sterility Care
Sterile unless package is opened or damaged
GS77
Sterile Latex Surgical Gloves
Healthline
Packaging Artwork:
Inner
Outer
290MM
150MM
Colour guide
• Powder free
• 30cm cuff
• Micro roughened
• Low modulus latex
Black
Pantone 201 C
Latex Surgical Gloves
Biotex L
PAIRS
Healthline
PEEL TO OPEN
50
Biotex L
Latex Surgical Gloves
This product’s principle intended purpose is medical and as such it complies with the requirements of the Medical
Devices Directive 93/42/EEC and subsequent amendments. These gloves are manufactured to the standards set by
the EN455 series ‘Medical Gloves for Single Use’ and BS EN ISO 11137 - Sterilisation of Health Care Products.
Powder free - eliminates powder associated transfer of latex proteins and chemical allergens, the drying effects of
powder on the skin and powder induced irritation.
WARNING:
• Contains natural rubber latex, which can cause allergic reactions, including anaphylactic responses.
• Contains ZDBC and ZDEC chemicals, which can cause type IV skin irritations and contact dermatitis.
225MM
124mm
DE
50
PAIRS
50
Healthline
PAIRS
Pouch
50
Healthline
PAIRS
Gants chirurgicaux - Latex - Non poudré
FR
Guantes quirúrgicos - Latex - Sin polvo
ES
NL
Chirurgische Handschoenen - Latex - Ongepoederd
Luvas cirúrgicas - Latex - Sem pó
PT
CS
Chirurgické rukavice - Latexové - Bez pudru
PL
Rękawice chirurgiczne - Lateksowe - Bezpudrowe
SV
Kirurgiska Handskar - Latex - Puderfria
DA
Kirurgiske handske - Latex - Pudderfri
Leikkauskäsineet - Latex - Puuteroimaton
FI
Red when irradiated
OP-Handschuhe - Latex - Puderfrei
Healthline
NO
Kirurgiske handsker - Latex - Pudderfri
RO
Mănuși chirurgicale - Latex - Fără pudra
BG
Хирургически ръкавици - Латекс - без пудра
AR
‫ ﺑﺪﻭﻥ ﺑﻮﺩﺭﺓ‬- ‫ ﺍﻟﻼﺗﻜﺲ‬- ‫ﺍﻟﻘﻔﺎﺯﺍﺕ ﺍﻟﺠﺮﺍﺣﻴﺔ‬
Biotex L
Latex Surgical Gloves
Biotex L
Latex Surgical Gloves
Biotex L
Healthline
Latex Surgical Gloves
STAMP
POWDER
Class IIa
Sterile
Medical
Device
STERILE R
Biotex L
Sterile unless package is opened or damaged
M HML, PO Box 85, SM4 9AW, UK.
Made in Malaysia
Class IIa
Sterile
Medical
Device
STERILE R
Class IIa
Sterile
Medical
Device
• Powder free
• 30cm cuff
• Micro roughened
• Low modulus latex
For single use only. Keep in a cool dry place, away from direct sunlight or fluorescent light
• Powder free
• 30cm cuff
• Micro roughened
• Low modulus latex
STERILE R
Sterile unless package is opened or damaged
Sterile unless package is opened or damaged
Class IIa
Sterile
Medical
Device
STERILE R
Latex Surgical Gloves
Sterile unless package is opened or damaged
238mm
1
• Powder free
• 30cm cuff
• Micro roughened
• Low modulus latex
285mm
PAIR
WARNING:
• Contains natural rubber latex,
which can cause allergic reactions,
including anaphylactic responses.
Class IIa
Sterile
Medical
Device
• Contains ZDBC and ZDEC
chemicals, which can cause type IV
skin irritations and contact dermatitis.
STERILE R
For single use only. Keep in a cool dry place,
away from direct sunlight or fluorescent light
M
HML, PO Box 85, SM4 9AW, UK.
Made in Malaysia
Dimensions:
Pouch: L152mm x W285mm
Dispenser: L290mm x W150mm x H225mm
Outer: L588mm x W308mm x H237mm
Barcodes:
Size
5.5
Sterile unless package is opened or damaged
152mm





PANTONE 201 C
80% K (Black)
60% K (Black)
40% K (Black)
30% K (Black)
6
6.5
7
7.5
8
8.5
9
Inner
-
5052755003893
5052755003909
5052755003916
5052755003923
5052755003930
5052755003947
-
Outer
-
5052755003954
5052755003961
5052755003978
5052755003985
5052755003992
5052755004005
-
Packaging Symbols:
g
N
H
M
Lot number
0086
Class 1
Sterile
Medical
Device
Compliant with the
Medical Devices
Directive
Date of manufacture
D
Single use do not re-use
Use by
u
Contains Latex
Manufacturer
POWDER
AQL
1.5
STERILE R
p
w
5:
Powder free
l25:
Keep dry
Keep away from
sunlight
Temperature
limitation
Recyclable
packaging
Acceptable
quality level
Sterlisation by
gamma irradiation
GS77/APR2014
0044 (0) 208 335 3636
0044 (0) 208 335 0300 sales@hpchealthline.co.uk
HPC Healthline Limited, Colwood House, 158 Garth Road, Morden, Surrey, SM4 4LZ, England
GS680/Oct 2013
www.hpchealthline.co.uk
www.facebook.com/hpchealthline
#hpchealthline