Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

P.T. Irama Dinamika Latex · Predicate Candidate Screening

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

95 daysmedian FDA review time

227 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days
K984449	NATURAL RUBBER PRE-POWDERED COLORED & FLAVORED PATIENT EXAMI	P.T. Irama Dinamika Latex	1999-03-19	95
K981064	POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINAT	P.T. Irama Dinamika Latex	1998-11-05	227
K980848	HYPOALLERGENIC LATEX PATIENT EXAM GLOVES-PREPOWDERED	P.T. Irama Dinamika Latex	1998-04-28	55
K972306	POWDERFREE COLORED AND FLAVORED NITRILE COPOLYMER PATIENT EX	P.T. Irama Dinamika Latex	1997-09-12	85
K965155	LATEX EXAM GLOVES	P.T. Irama Dinamika Latex	1997-03-05	72
K962518	NITRILE COPOLYMER PATIENT EXAMINATION GLOVES	P.T. Irama Dinamika Latex	1996-12-19	175
K963771	CHLOROPRENE EXAM GLOVES	P.T. Irama Dinamika Latex	1996-12-19	91
K960315	FLAVORED LATEX PATIENT EXAMINATION	P.T. Irama Dinamika Latex	1996-11-20	302
K953462	PATIENT EXAMINATION GLOVES	P.T. Irama Dinamika Latex	1996-01-04	164
K941787	LATEX EXAM GLOVES	P.T. Irama Dinamika Latex	1994-10-19	191
K913776	PATIENT EXAMINATION GLOVES	P.T. Irama Dinamika Latex	1991-11-07	86

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