TotalGlove brochure (Engels).indd

A
safe
feeling
Stay in touch with your second skin
A breakthrough solution
Latex allergy explained
Total Glove Company Sdn Bhd (Total Glove) is
the joint venture company of Latexx Partners Bhd
and the Dutch based R&D company Budev BV.
An allergy is a hypersensitive immunologic
response to a substance, i.e. the allergen.
I N N O VAT I O N I N L AT E X P R O T E C T I O N
MPXX
TM
stands for Maximum Protection Latex and
entails a unique global patented batch washing
SYMP TOMS
The symptoms of Type I allergy are amongst others
urticaria (hives), hay fever type of symptoms and
allergens are reduced to unquantifiable levels,
PROTEINS AND ALLERGENS
Raw latex contains approximately 200 different types
asthma. More severe symptoms occur such as
With Latexx Partners being one of the global leading
manufacturing companies of examination gloves this
including the major allergens Hev b1, Hev b3,
of proteins. Fourteen proteins are listed by the WHO as
drop in blood pressure resulting in a possible loss of
set-up combines constant and reliable product and
Hev b5 and Hev b6.02. Furthermore the chemical
an allergen, whereby it is clinically proven that four of
consciousness or severe breathing difficulty.
service levels with the breakthrough technology for
residues, such as thiurams, dithiocarbamates and
them are the major allergens. These four are called Hev
eliminating Natural Rubber Latex (NRL) allergens and
mercaptobenzothiazoles, are reduced to undetectable
b1, Hev b3, Hev b5 and Hev b6.02.
chemical residues, MPXX™. The MPXX™ technology
levels. This enables you to fight latex allergy Type I
reduces the risk of latex allergy Type I and Type IV to a
and IV and therefore improves our public health and
CHEMIC ALS
maximum.
occupational safety.
HOWEVER, there are two types of allergies related to
process. The main advantage of MPXX™ is that
anaphylaxis, a condition in which there is a severe
The symptoms of Type IV allergy include red itchy scaly
rash, often localised to the area of use, i.e. wrists and
forearms, but which may spread to other areas.
natural rubber latex: Type I caused by the proteins;
Gloves can also cause irritant contact dermatitis. This
With the main aim of preventing contamination
Cleantexx - MPXX™ gloves are the highest quality
Type IV caused by chemical residue, mostly coming
is however not a true allergy. A choice of a good glove
between care-givers and patients, today’s medical
available in the industry and meet the international
from accelerators that are used to convert the raw
and the correct use are in this respect important.
gloves are made of several different materials like NRL,
requirements of ASTM International, the European
material to a usable item. The chemicals that most
nitrile and vinyl, powdered or unpowdered.
Standard EN 455, part 1 – 3 and other equivalent
likely cause a reaction are thiurams, dithiocarbamates
international standards. Besides fulfilling all
and mercaptobenzothiazoles. Type IV allergy is also
Due to the risk of latex allergy Type I cases alternative
requirements under these standards, Cleantexx -
known as allergic contact dermatitis.
materials like nitrile and vinyl have become widely
MPXX™ gloves have been subjected to the most
used. However, they lack the expected tactility and
comprehensive combination of test methods available,
dexterity and they cause in a number of cases latex
including extensive user tests.
allergy Type IV, known as allergic contact dermatitis,
due to the chemical residue of substances used in the
Cleantexx - MPXX™ gloves are the solution to rising
production process.
healthcare expenses and budget constraints.
The solution is the NRL Cleantexx - MPXX™
Cleantexx - MPXX™ gloves are available in two types,
examination glove.
Cleantexx Premium (non-grip) and Cleantexx Classic
(grip).
Did you know that...
Although Type I allergy does not occur in response to alternative materials like nitrile due
to the absence of proteins, this material typically contains the same chemical residue (MBT)
that can cause serious Type IV allergy (allergic contact dermatitis). This is a career-threatening
issue and can cause the loss of valuable Healthcare staff. It could be difficult to find an
alternative glove once the allergen has been identified. It is therefore important to source a
glove that is considered clean, evidenced by various available test methods.
Secure & clean
product
Cleantexx - MPXX™ gloves are sourced from Latexx
Latexx Partners Bhd started its operation in 1988 and
Partners Bhd, located in Kamunting Industrial Estate,
is today one of the global largest medical examination
north of peninsular Malaysia, with close proximity
gloves producers in the world. Actually, it is presently
to Penang seaport and Penang international airport.
the largest glove manufacturing company with all
Thanks to Total Glove’s set-up we are able to carry out
its factories built in one single site. The company
outstanding research, executed by highly qualified
embarked on an aggressive expansion plan. By 2013,
staff in state-of-the-art laboratories. Besides the
a target of 12 billion gloves is set. And, by year 2015 a
application of the MPXX™ technology, much of our
capacity target of 15 billion gloves per annum should
research is focused on product development and plant
be achieved.
technology improvements. Our result-driven research
efforts have made it possible to manufacture MPXX™
PXX™
As part of our total customer satisfaction approach,
Cleantexx - MPXX TM gloves were tested with various
users (medical staff). One of the conclusions is that
Cleantexx - MPXX TM gloves score significantly better
than regular gloves.
CLE ANTE X X – MPX X ™ GLOVES ARE
A P P R E C I AT E D M O R E T H A N R E G U L A R G L O V E S
treated examination gloves with
th the best protective
In line with our commitment to quality, we pledge to
serve both internal and external customers, based on
the following commitments:
• No compromise on the quality of incoming raw materials
IMPORTANCE
features, leading
ing to maximum customer satisfaction.
n
Ease to put on
g
Comfort when wearing
Sense of touch
Strength of glove
Fit
Grip
Ease to take off
• Total customer satisfaction.
• Strive to make our products even safer and more
reliable through continuous improvement.
check-points
• Quality assurance performed at specific check-poin
nts
Grip when using wet instruments
Wave 1
Smell
Wave 2
Colour
Wave 3
Colour change
like Incoming Material Inspections, Process Quality
Regular
0%
Control, In-process Lot Inspection and Pre-shipmen
Pre-shipment
nt
20%
40%
60%
80%
100%
Inspection.
AF TER THREE WEEK S OF USE, CLEANTEX X – MPX X™
IMPORTANCE
G L O V E S S C O R E S I G N I F I C A N T LY B E T T E R T H A N R E G U L A R G L O V E S
Ease to put on
Sense of touch
Fit
Ease to take off
Smell
Colour change
0%
Cleantexx
20%
40%
Source: Skim Market Research
60%
80%
100%
Regular
Test results
Overview
CLEANTEX X PREMIUM (NON - GRIP)
C L E A N T E X X C L A S S I C (G R I P )
THICKNESS (SINGLE WALL)
• Unquantifiable protein
Cuff (at 25 mm from cuff end)
• Undetectable chemical residue
Palm (at centre of palm)
min. 0.12
• Natural Rubber Latex
Finger (at 13 mm from the extreme tip)
min. 0.15
LOCATION OF
THICKNESS MEASUREMENT
SINGLE WALL
THICKNESS (mm)
Besides complying with the standard requirements under the ASTM International and EN 455
standards, Cleantexx – MPXX™ gloves are constantly subjected to a variety of tests, ensuring the
highest quality available for the environment, the user and avoidance of latex allergy Type I and
Type IV. All tests are executed with well respected international accredited laboratories.
min. 0.10
TEST RESULTS
INTERNATIONAL
STANDARD
CLEANTEXX GLOVES
Modified Lowry
EN 455-3
ASTM D5712
Not detected
Eliza inhibition test antigenic protein
ASTM D6499
Not detected
RAST inhibition
EN 455-3
Not detected
Amino acid analysis by High Pressure
Liquid Chromatography (HPLC)
EN 455-3
Not detected
FITkit
ASTM D7427
Unquantifiable
• Non-sterile
• Single use
• Biodegradable
• Easy donning
PALM WIDTH
AND LENGTH
• Ambidextrous
• Beaded cuff
• Powder free
PROTEIN LEVEL
Leachable protein levels comply with EN 455-3 and ASTM
D5712
ASTM D7427 Hev b1, Hev b3, Hev b5 and Hev b6.02
Unquantifiable
SIZE
PALM WIDTH
(mm)
LENGTH
(in mm)
X-small
75 ± 5
min. 240
Small
85 ± 5
min. 240
Medium
95 ± 5
min. 240
Large
106 ± 5
min. 240
X-large
min. 110
min. 240
TENSILE PROPERTIES
CHARACTERISTICS
REFERENCE STANDARD
BEFORE AGING
AFTER AGING 7 DAYS @ 70 ºC ± 2 HOURS
Tensile Strength (MPa)
ASTM D3578
min. 18
min. 14
Ultimate Elongation (%)
ASTM D3578
min. 650
min. 500
Force at Break (N)
EN 455, part 2
No protein bands or the molecular
weight markers have been observed
SDS-Page*
EN 1186-3:2002
EN 1186-14:2002
Overall migration
Primary skin irritation
Non-irritant
Chemical permeation (PPE)
EN 374-1/3
5 out of 12 chemicals
Chemical residue
MRB in house
Not detected
Cytotoxicity
MTT ASSAY ISO 10993:5
Pass
Barrier defect
ASTM D5151
AQL 1.5
Migratable N-Nitrosamines
EC 1935/2004
Pass
All tests were executed by international accredited test institutions and the results are available upon your
our specific request.
* On the washing fluid.
≥6
Did you know that...
EN 455
455,, 1-3
1-3
Not detected or below
permissible limit
Undetectable levels of chemical residue
in the Cleantexx MPXXTM gloves
enhances biocompatibility and strongly
reduces Type IV allergy risk.
Budev BV
Bloemendaalseweg 139
2061 CH Bloemendaal
The Netherlands
T: +31 (0) 23 525 50 74
[email protected]
www.budev.com
EN 455, 1-3