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FDA 510k Registration
*US Food & Drug Administration |
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Standard Malaysian Glove (SMG)
*Malaysian Rubber Board, Malaysia |
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Europe CE 0120 Mark Directive 93/42/EEC
*SGS United Kingdom Ltd |
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Europe CE 0120 Mark Directive 89/686/EEC
*SGS United Kingdom Ltd |
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Therapeutic Goods Administration, Australia
*TGA Australia |
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Canadian General Standards Board Listing
*CGSB, Canada |
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NF 101 Standards, France
*French AFNOR Certification |
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Medical Device Licence, Canada
*Medical Device Bureau, Health Canada |
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CMDCAS ISO 13485 : 2003
*SGS System & Services Certification Canada Inc. |
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Quality Management System ISO 9001: 2000
*SGS United Kingdom Ltd |
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Quality Management System ISO 9001: 2000
*TUV CERT Certification by RWTUV Germany |
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Quality Management System ISO 9001: 2000
*SIRIM QAS International Sdn Bhd, Malaysia |
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EEC Commission Directive 90/128/EEC
*SGS United Kingdom Ltd |
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