Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terang Nusa Sdn Bhd

FDA 510(k) & PMA Approved Devices — 24 products

Total Devices24
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K170779 Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable proteinLYY2017-05-24 View
510(k) K161932 Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove PinkLZA2016-11-28 View
510(k) K153510 Powder Free Polychloroprene Examination Glove GreenLZA2016-03-21 View
510(k) K110698 NUZONE X2T CHEMO, POLYCHLOROPRENE SYNTHETIC TAN SURGICAL GLOVES POWDER FREEKGO2011-12-07 View
510(k) K102230 NUGARD NITILE GREY COLORLZA2010-09-10 View
510(k) K102119 SUR-G GLOV AND MAXITEXKGO2010-08-27 View
510(k) K083337 NUGARD, SENSIFLEX PROCEDURE EXAMINATION GLOVESLYY2009-01-27 View
510(k) K052837 SENSIFLEX PLUS POLYMER COATED LATEX POWDER-FREE SURGICAL GLOVE WITH ALOE VERAKGO2005-11-21 View
510(k) K051562 NUZONE SYNGARD POWDER FREE POLYMER COATED POLYISOPRENE STERILE SURGICAL GLOVE - ALOE VERA COATED GREEN COLOURKGO2005-10-20 View
510(k) K051563 NUZONE X2A NEOPRENE - POLYISOPRENE POWDER FREE SURGICAL GLOVES POLYMER AND ALOE COATEDKGO2005-06-20 View
510(k) K051094 NUZONE X2T POLYCHLOROPRENE SYNTHETIC TAN SURGICAL GLOVE - POWDERFREEKGO2005-06-06 View
510(k) K041437 MAXITEX LATEX NEURO PF SURGICAL GLOVE POWDERFREEKGO2004-09-16 View
510(k) K041436 SYNTHETIC SURGICAL GLOVE-POWDERFREE NUZONE X2KGO2004-08-20 View
510(k) K010438 MAXITEX DUPLEX POWDER FREE LATEX STERILE SURGEON GLOVES PROTEIN LABELING CLAIM (50 MICRGRAMS OR LESS)KGO2001-05-01 View
510(k) K010439 MAXITEX DUPLEX STERILE LATEX POWDERED SURGEON GLOVES WITH PROTEIN LABELING CLAIM (100 MICROGRAMS OR LESS)KGO2001-05-01 View
510(k) K003547 NUGARD DG POWDERED GREEN-MINT LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS)LYY2000-12-21 View
510(k) K003545 NUGARD POWDERFREE, BLUE POLYMER COATED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LELYY2000-12-21 View
510(k) K000178 NUZONE NITRILE SURGICAL GLOVES, POWDERED, GREENKGO2000-05-23 View
510(k) K000179 NUZONE NITRILE SURGICAL GLOVES POWDER FREEKGO2000-05-15 View
510(k) K990488 SENSIFLEX POWDERFREE LATEX EXAMINATION GLOVELYY1999-05-28 View
↑