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Examination glove standards and Malaysian product
certification
by
Dr Abdul Kadir
Malaysia’s export of rubber medical gloves
Source: Global Trade Atlas
1,081,19
1,471,71
2,11 2,03
0.0
0.5
1.0
1.5
2.0
2.5
2004 2005 2006 2007 2008 2009
US$ billion
45,0 45,949,1
48,651,5
% share of world’s export
50,7
Malaysia’s export of surgical gloves
Source: Global Trade Atlas
% share of world’s export
518571
616 618
751713
0
100
200
300
400
500
600
700
800
2004 2005 2006 2007 2008 2009
US$ million
33,630,9 31,4 33,9
34,6 31,2
0,901,00
1,26
1,48
1,82 1,79
0.00.20.40.60.81.01.21.41.61.82.0
2004 2005 2006 2007 2008 2009
US$ billion
Malaysia’s export of examination gloves
Source: Global Trade Atlas
% share of world’s export
48,1 49,653,1
51,1
53,5 55,2
Malaysia exports rubber gloves to over 180
countries around the world
327 355
452
556
663620
0
100
200
300
400
500
600
700
2004 2005 2006 2007 2008 2009
US$ million
30,329,8
30,7
32,5
31,530,5
% share of Malaysia’s export
Malaysia’s export of medical gloves to EU
Source: Global Trade Atlas
1.031.19
1.40
1.681.56
0.0
0.2
0.4
0.6
0.8
1.0
1.2
1.4
1.6
1.8
2005 2006 2007 2008 2009
US$ billion
34,437,9
39,6
39,539,8
EU imports of medical gloves
% imports from Malaysia
Source: Global Trade Atlas
European Committee for Standardization
ASTM International
International Organization for Standardization
Major developers and publishers of standards
Major medical examination glove standards
→European standards on medical gloves for single use EN 455-1:2000 Freedom from holes EN 455-2:2009 Physical properties EN 455-3:2006 Biological evaluation EN 455-4:2009 Shelf life determination
→ASTM D 3578:2005 Standard specification for rubber examination gloves
→ISO 11193-1:2008 Single use medical examination gloves – Part 1: Specification for gloves made from rubber latex or rubber solution
Freedom from holes
DimensionsPhysical props.
Leach. protein
Powder residue
(P)
Powder amount
(PF)
Shelf life
EN
ASTM
ISO
Requirements of EN, ASTM and ISO standards on medical gloves
Inspection level
AQL Volume of water (cm3)
Observation
EN 455–1 G-1 1,5 1000 +/- 50 1st: Immediately2nd: After 2 – 3 min
ASTM D3578 G-1 2,5 Minimum 1000 1st: Immediately2nd: After 2 min
ISO 11193–1 G-1 2,5 1000 +/- 50 1st: Immediately2nd: After 2 – 4 min
Freedom from holes
This makes EN 455-1 the most stringent of the three standards.
PropertyInspection
levelAQL Unaged Aged
Cutter width
EN 455–2 Force at break
13 samples from each lot
9,0 N 6,0 N 3,0 mm
ASTM D3578 Tensile strength
S-2 4,0 18 MPa 14 MPa Not specified
ISO 11193–1 Force at break
S-2 4,0 7,0 N 6,0 N 4,0 mm
Applicable during shelf
life
Physical properties for NR gloves
T = FA
where:T is tensile strengthF is force at breakA is cross-sectional area
of test specimen
F
F
bw
A = b * w
Relationship between force at break and tensile strength
Force
Extension
3 mm
4 mm
Tensile strength
Extension
3 mm & 4 mm
Cutter width
Tensile strength is material property
Force at break (N) Tensile strength (MPa)
Unaged Aged Unaged AgedCutter width
EN 455–2 9,0 6,0 25 16,7 3,0 mm
ASTM D3578 18 14 Not specified
ISO 11193–1 7,0 6,0 14,6 12,5 4,0 mm
Note: Tensile strength is calculated from the force at break for gloves of typical thickness of 0.12mm.
Can be met by thicker
gloves
Is EN 455-2 force at break requirement too high?
Applicable during shelf life.
Too high?Too low?
Harmonization of EN and ISO standards
EN and ISO standards are far apart, with the ISO standard requirements for physical properties well below those of EN
Harmonization of ISO and EN standards on medical gloves could provide some rationalization of the current disparate standards
The Vienna Agreement signed between CEN and ISO in 1991 promotes cooperation between CEN and ISO
A consensus global standard could only be achieved through the work of the Global Harmonization Task Force (GHTF)
The SMG scheme is a voluntary third party product certification scheme for NR examination gloves, both powdered and powder-free
The SMG specification establishes requirements for:
Freedom from holes
Physical properties
Protein content
Powder content
The scheme is operated by the Malaysian Rubber Board, an ISO/IEC Guide 65 body, authorized by Standards Malaysia
The rigorous certification procedure offers the assurance that SMG gloves comply with the requirements of the SMG specification
POWDER-FREE
POWDERED
Standard Malaysian Glove scheme
SMG EN 455–2 ASTM D3578
Unaged force at break, N 9 9 18 MPa = 6,5 N
Unaged elongation at break, % 650 Not specified 650
Aged force at break, N 6 6 14 MPa = 5,0 N
Aged elongation at break, % 500 Not specified 500
Note: Cutter width to be changed from 4 mm to 3 mm to meet EN requirements.
Standard Malaysian Glove (SMG) physical properties to be revised to meet both EN and
ASTM standards
Inspection level AQLG-1 1.5
The requirement is the same as in
EN455-1.
Freedom from holes requirementof SMG gloves
Dimension Size (mm)
Palm widthExtra-small Small Medium Large Extra-large
< 80 80 ± 10 95 ± 10 110 ± 10 > 110
Length 240 mm minimum
Thickness at palm and
finger0.08 mm minimum
EN455-2 does not specify minimum thickness.
Dimension requirements of SMG gloves
Powder-free Powdered
Protein, μg/dm2 50 200
Powder, mg/glove 2 150
EN455-3 requires monitoring of
process limit of leachable protein.
EN455-3 considers gloves containing
more than 2 mg of powder as
powdered gloves.
Protein and powder limits of SMG gloves
• Malaysia is the world’s leading exporter of medical gloves
• The many standards that are applicable lead to higher cost to both Malaysian producers and importers/users of Malaysian gloves
• SMG examination gloves are certified for compliance with the EN, ASTM and ISO standards
Conclusion
THANKYOU
