FDA 510(k) Applications Submitted by CHIN-GUAN LOW

FDA 510(k) Number Submission Date Device Name Applicant
K000178 01/20/2000 NUZONE NITRILE SURGICAL GLOVES, POWDERED, GREEN TERANG NUSA SDN BHD
K000179 01/20/2000 NUZONE NITRILE SURGICAL GLOVES POWDER FREE TERANG NUSA SDN BHD
K010439 02/12/2001 MAXITEX DUPLEX STERILE LATEX POWDERED SURGEON GLOVES WITH PROTEIN LABELING CLAIM (100 MICROGRAMS OR LESS) TERANG NUSA SDN BHD
K010438 02/13/2001 MAXITEX DUPLEX POWDER FREE LATEX STERILE SURGEON GLOVES PROTEIN LABELING CLAIM (50 MICRGRAMS OR LESS) TERANG NUSA SDN BHD
K990840 03/15/1999 NUGARD NITRIL POWDERFREE NITRILE EXAMINATION GLOVE TERANG NUSA SDN BHD
K990841 03/15/1999 NUGARD NITRIL NITRILE EXAMINATION GLOVE TERANG NUSA SDN BHD
K041436 05/28/2004 SYNTHETIC SURGICAL GLOVE-POWDERFREE NUZONE X2 TERANG NUSA SDN BHD
K041437 05/28/2004 MAXITEX LATEX NEURO PF SURGICAL GLOVE POWDERFREE TERANG NUSA SDN BHD
K051562 06/13/2005 NUZONE SYNGARD POWDER FREE POLYMER COATED POLYISOPRENE STERILE SURGICAL GLOVE - ALOE VERA COATED GREEN COLOUR TERANG NUSA SDN BHD
K051563 06/13/2005 NUZONE X2A NEOPRENE - POLYISOPRENE POWDER FREE SURGICAL GLOVES POLYMER AND ALOE COATED TERANG NUSA SDN BHD
K003545 11/17/2000 NUGARD POWDERFREE, BLUE POLYMER COATED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LE TERANG NUSA SDN BHD
K003547 11/17/2000 NUGARD DG POWDERED GREEN-MINT LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS) TERANG NUSA SDN BHD


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