Our Business: Quality Assurance |
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| Quality Management System Awarded to Supermax
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FDA 510K Certification
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FDA 510k registration |
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With US FDA on Low Powder Hypoallergenic Latex Examination Gloves |
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FDA 510k registration |
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With US FDA on Powder Free Latex Examination Gloves with Protein Content Labeling Claim (50 mgs or less) |
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FDA 510k registration |
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With US FDA on Latex Powdered Exam Gloves with 70 mgs or Less Total Water Extractable Protein Per Gram. |
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FDA 510k registration |
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With US FDA on Polymer Coated Powder Free Latex Examination Gloves(50 mgs or less protein labeling claim) |
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FDA 510k registration |
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With US FDA on Powdered Nitrile Examination Gloves |
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FDA 510k registration |
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With US FDA on Aurelia Chlorinated Powder Free Latex Medical Examination gloves with Aloe Vera & Ginseng with Protein Labeling Claim (50 mgs or less) |
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FDA 510k registration |
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With US FDA on Powder Free Nitrile Examination Gloves |
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FDA 510k registration |
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With US FDA on Green Peppermint Flavored Powdered Latex Examination Gloves |
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FDA 510k registration |
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With US FDA on Green Peppermint Flavored Powder Free Latex Examination Gloves with Protein Content Labeling Claim (50 mgs or less) |
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FDA 510k registration |
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With US FDA on Sterile Powdered Latex Examination Gloves |
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FDA 510k registration |
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With US FDA on Sterile Powdered Latex Surgeon Gloves |
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FDA 510k registration |
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With US FDA on Sterile Powder Free Latex Surgeon gloves with Protein Labeling claim (50 mgs or less) |
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FDA 510k registration |
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With US FDA on Green Powder Free Nitrile Medical Examination Gloves with Peppermint Flavour. |
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Product Certification
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Australian Register of Therapeutic Goods (ARTG) |
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Authorization for the Use of Conformity Identification Seal from OCP, Brasil
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Standard Malaysian Glove Certificate of Accreditation from Malaysian Rubber Board
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Directive 93/42/EEC Annex V (Sterility only) Sterile Gloves from SGS, Belgium |
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Regulation (EU) 2016/425 from SGS, Finland
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Regulation (EU)2016/245 as brought into UK Law and amended from SGS,UK |
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Test Conduct on Gloves
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Watertightness : ASTM D5151, EN455-1
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Physical Properties : |
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1) Dimension : ASTM D3767, EN455-2 |
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2) Tensile : ASTM D412 & ASTM D573, EN455-3 |
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Protein Testing : ASTM D5712, EN455-3
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Residual Powder Testing : ASTM D6124, EN455-3 |
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Biocompatibility Testing |
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Bioburden Testing |
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*Samples sent to microbiological lab for testing |
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Quality Policy
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As a leading medical glove manufacturer, Supermax Glove Manufacturing Sdn Bhd shall be |
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Committed to:- |
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Produce gloves to attain customer satisfaction and to meet the requirements of customer , |
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applicable regulatory requirements and glove standards |
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Promote teamwork and employee satisfaction to ensure a conducive work environment. |
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Maintain the effectiveness of Quality Management System and undertake continual |
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improvement in quality system activities.
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Meeting expectation and requirement of interested parties. |
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