Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Terang Nusa Sdn Bhd — Predicate Candidate Screening

26 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

78 daysmedian FDA review time

142 days90th percentile

26clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K170779	Nugard Black Powder Free Latex Examination Glove, Polymer Co	Terang Nusa Sdn Bhd	2017-05-24	70	0
K161932	Powder Free Polychloroprene Examination Glove Blue, Powder F	Terang Nusa Sdn Bhd	2016-11-28	137	0
K153510	Powder Free Polychloroprene Examination Glove Green	Terang Nusa Sdn Bhd	2016-03-21	105	0
K151392	Sensiflex Plus Sterile Latex Green Surgical Glove Powder Fre	Terang Nusa Sdn Bhd	2015-09-18	115	0
K140355	SENSIFLEX PLUS STERILE LATEX SURGICAL GLOVE POWDERFREE WITH	Terang Nusa Sdn Bhd	2014-11-06	267	0
K110698	NUZONE X2T CHEMO, POLYCHLOROPRENE SYNTHETIC TAN SURGICAL GLO	Terang Nusa Sdn Bhd	2011-12-07	293	0
K102230	NUGARD NITILE GREY COLOR	Terang Nusa Sdn Bhd	2010-09-10	32	0
K102119	SUR-G GLOV AND MAXITEX	Terang Nusa Sdn Bhd	2010-08-27	30	0
K083337	NUGARD, SENSIFLEX PROCEDURE EXAMINATION GLOVES	Terang Nusa Sdn Bhd	2009-01-27	76	0
K052837	SENSIFLEX PLUS POLYMER COATED LATEX POWDER-FREE SURGICAL GLO	Terang Nusa Sdn Bhd	2005-11-21	46	0
K051562	NUZONE SYNGARD POWDER FREE POLYMER COATED POLYISOPRENE STERI	Terang Nusa Sdn Bhd	2005-10-20	129	0
K051563	NUZONE X2A NEOPRENE - POLYISOPRENE POWDER FREE SURGICAL GLOV	Terang Nusa Sdn Bhd	2005-06-20	7	1
K051094	NUZONE X2T POLYCHLOROPRENE SYNTHETIC TAN SURGICAL GLOVE - PO	Terang Nusa Sdn Bhd	2005-06-06	39	0
K041437	MAXITEX LATEX NEURO PF SURGICAL GLOVE POWDERFREE	Terang Nusa Sdn Bhd	2004-09-16	111	0
K041436	SYNTHETIC SURGICAL GLOVE-POWDERFREE NUZONE X2	Terang Nusa Sdn Bhd	2004-08-20	84	0
K010438	MAXITEX DUPLEX POWDER FREE LATEX STERILE SURGEON GLOVES PROT	Terang Nusa Sdn Bhd	2001-05-01	77	0
K010439	MAXITEX DUPLEX STERILE LATEX POWDERED SURGEON GLOVES WITH PR	Terang Nusa Sdn Bhd	2001-05-01	78	0
K003547	NUGARD DG POWDERED GREEN-MINT LATEX EXAMINATION GLOVES WITH	Terang Nusa Sdn Bhd	2000-12-21	34	0
K003545	NUGARD POWDERFREE, BLUE POLYMER COATED LATEX EXAMINATION GLO	Terang Nusa Sdn Bhd	2000-12-21	34	0
K000178	NUZONE NITRILE SURGICAL GLOVES, POWDERED, GREEN	Terang Nusa Sdn Bhd	2000-05-23	124	0
K000179	NUZONE NITRILE SURGICAL GLOVES POWDER FREE	Terang Nusa Sdn Bhd	2000-05-15	116	0
K990488	SENSIFLEX POWDERFREE LATEX EXAMINATION GLOVE	Terang Nusa Sdn Bhd	1999-05-28	101	0
K990841	NUGARD NITRIL NITRILE EXAMINATION GLOVE	Terang Nusa Sdn Bhd	1999-05-17	63	0
K990840	NUGARD NITRIL POWDERFREE NITRILE EXAMINATION GLOVE	Terang Nusa Sdn Bhd	1999-05-17	63	0
K982957	SENSIFLEX POWDERFREE SURGEON'S GLOVE	Terang Nusa Sdn Bhd	1999-01-13	142	1
K891245	PATIENT EXAMINATION GLOVES (LATEX)	Terang Nusa Sdn Bhd	1989-03-22	14	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda