We emphasize on stringent quality control procedures in line with ISO 9001 and in strict compliance with ASTM and EN455 Standards. Our manufacturing plant and the entire manufacturing process are subject to most stringent quality tests and are regularly checked by TÜV and FDA. With our achievement to maximum quality and safety, DR.BOO, thereby, have a leading position in European, American and Japan gloves market and meet the latest market requirements.
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1998 - To Date |
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US FDA (Food and Drug Administration) |
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1991 – 1997 |
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TIS 1056 (Thai Industrial Standard) |
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1997 - 2001 |
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TIS 1056 (Thai Industrial Standard) |
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2001 - To Date |
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TIS 1056 (Thai Industrial Standard) |
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1996 - To Date |
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Thai FDA Registration |
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2000 – 2003 |
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DIN EN ISO 9002: 1994 (Quality Management System) |
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EN ISO 13488 (Medical devices) |
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EN 46002 : 1996 |
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2004 - To Date |
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EN ISO 9001 : 2000 (Quality Management Systems) |
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EN ISO 13485 : 2003 (Medical devices- Quality Management Systems) |
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2001 - 2004 |
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Thailand Brand ME 0020/01 (Department of Export Promotion) |
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2004 - 2007 |
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Thailand Brand ME 0020/04 (Department of Export Promotion) |
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2007 - To Date |
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Thailand Brand ME 0020/07 (Department of Export Promotion) |
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2004 – To Date |
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CE MARK |
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EN 455 - 1 : 2000 (Requirements and Testing for Freedom from Holes) |
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EN 455 - 2 : 2000 (Requirements and Testing for Physical Properties) |
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EN 455 - 3 : 1999 (Requirements and Testing for Biological Evaluation) |
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2006 |
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GMP Award (Good Manufacturing Practice) by Thai FDA Registration |
