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Quality Assurance |
Quality Management System Awarded to Supermax
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ISO 9001:2000 SIRIM, Malaysia |
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Special Regulation NF101 AFNOR, LNE, France |
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Certificate of Good Manufacturing Practice of Medical Devices Manufacturer by Anvisa, Brasil |
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ISO 9001:2000 BVQI |
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CE Mark on Sterilised Latex Gloves audited by SGS, UK and SGS, Malaysia |
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ISO 13485: 2003 audited by Standard Council of Canada, accredited registrar, SGS Canada |
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Accreditation Certificate of Foreign Medical Device Manufacturer by Ministry of Health, Labour and Welfare Japan |
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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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Certificate of Listing from Canadian General Standards Board (CGSB), Canada |
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Certificate of Listing No: AUST L 63625 from TGA, Australia |
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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, UK |
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Directive 89/686/EEC Article 11B-PPE from SGS, UK |
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Test Conduct on Gloves
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Watertightness : ASTM D5151:99 |
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Physical Properties : |
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1) Dimension : ASTM D3767:01 |
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2) Tensile : ASTM D412:98 & ASTM D573:99 |
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Protein Testing : ASTM D5712:99 |
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Residual Powder Testing : ASTM D6124:01 |
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Biocompatibility Testing |
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*Samples sent to CPTC, USA for testing |
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Bioburden Testing |
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*Samples sent to microbiological lab for testing |
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