feeling Stay in touch with your second skin

Transcription

1 safe A feeling Stay in touch with your second skin

2 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. INNOVATION IN LATEX PROTECTION MPXX TM stands for Maximum Protection Latex and entails a unique global patented batch washing process. The main advantage of MPXX is that An allergy is a hypersensitive immunologic response to a substance, i.e. the allergen. PROTEINS AND ALLERGENS SYMPTOMS The symptoms of Type I allergy are amongst others urticaria (hives), hay fever type of symptoms and asthma. More severe symptoms occur such as With Latexx Partners being one of the global leading allergens are reduced to unquantifiable levels, Raw latex contains approximately 200 different types anaphylaxis, a condition in which there is a severe 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. The symptoms of Type IV allergy include red itchy scaly chemical residues, MPXX. The MPXX technology reduces the risk of latex allergy Type I and Type IV to a levels. This enables you to fight latex allergy Type I and IV and therefore improves our public health and CHEMICALS rash, often localised to the area of use, i.e. wrists and forearms, but which may spread to other areas. maximum. occupational safety. HOWEVER, there are two types of allergies related to 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 examination glove. Cleantexx - MPXX gloves are available in two types, 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.

3 Secure product & clean Cleantexx - MPXX gloves are sourced from Latexx Partners Bhd, located in Kamunting Industrial Estate, north of peninsular Malaysia, with close proximity to Penang seaport and Penang international airport. Thanks to Total Glove s set-up we are able to carry out outstanding research, executed by highly qualified staff in state-of-the-art laboratories. Besides the application of the MPXX technology, much of our research is focused on product development and plant technology improvements. Our result-driven research efforts have made it possible to manufacture MPXX treated examination gloves with the best protective features, leading to maximum customer satisfaction. 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 Total customer satisfaction. Strive to make our products even safer and more reliable through continuous improvement. Quality assurance performed at specific check-points like Incoming Material Inspections, Process Quality Control, In-process Lot Inspection and Pre-shipment Inspection. Latexx Partners Bhd started its operation in 1988 and is today one of the global largest medical examination gloves producers in the world. Actually, it is presently the largest glove manufacturing company with all its factories built in one single site. The company embarked on an aggressive expansion plan. By 2013, a target of 12 billion gloves is set. And, by year 2015 a capacity target of 15 billion gloves per annum should be achieved. 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. CLEANTEXX MPXX GLOVES ARE APPRECIATED MORE THAN REGULAR GLOVES IMPORTANCE Ease to put on Comfort when wearing Sense of touch Strength of glove Fit Grip Ease to take off Grip when using wet instruments Smell Colour Colour change 0% 20% 40% 60% 80% 100% Wave 1 Wave 2 Wave 3 Regular AFTER THREE WEEKS OF USE, CLEANTEXX MPXX GLOVES SCORE SIGNIFICANTLY BETTER THAN REGULAR GLOVES IMPORTANCE Ease to put on Sense of touch Fit Ease to take off Smell Colour change 0% 20% 40% 60% 80% 100% Source: Skim Market Research Cleantexx Regular

4 Overview Test results CLEANTEXX PREMIUM (NON-GRIP) CLEANTEXX CLASSIC (GRIP) Unquantifi able protein Undetectable chemical residue Natural Rubber Latex Non-sterile Single use Biodegradable Easy donning Ambidextrous Beaded cuff Powder free PROTEIN LEVEL Leachable protein levels comply with EN and ASTM D5712 ASTM D7427 Hev b1, Hev b3, Hev b5 and Hev b6.02 Unquantifiable THICKNESS (SINGLE WALL) LOCATION OF THICKNESS MEASUREMENT SINGLE WALL THICKNESS (mm) Cuff (at 25 mm from cuff end) min Palm (at centre of palm) min Finger (at 13 mm from the extreme tip) min PALM WIDTH AND LENGTH 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 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. TEST RESULTS Modified Lowry INTERNATIONAL STANDARD EN ASTM D5712 CLEANTEXX GLOVES Not detected Eliza inhibition test antigenic protein ASTM D6499 Not detected RAST inhibition EN Not detected Amino acid analysis by High Pressure Liquid Chromatography (HPLC) EN Not detected FITkit ASTM D7427 Unquantifiable SDS-Page* Overall migration Primary skin irritation EN :2002 EN :2002 No protein bands or the molecular weight markers have been observed Not detected or below permissible limit Non-irritant Chemical permeation (PPE) EN 374-1/3 5 out of 12 chemicals Chemical residue MRB in house Not detected TENSILE PROPERTIES CHARACTERISTICS REFERENCE STANDARD BEFORE AGING AFTER AGING 7 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 6 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 specific request. * On the washing fluid. Did you know that... EN 455, 1-3 Undetectable levels of chemical residue in the Cleantexx MPXX TM gloves enhances biocompatibility and strongly reduces Type IV allergy risk.

5 Budev BV Bloemendaalseweg CH Bloemendaal The Netherlands T: +31 (0) EN 455, 1-3