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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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