FDA applicant

P.T. Irama Dinamika Latex

Indonesia, ID11 decisions1991–19990 recalls

FDA records 11 decisions for P.T. Irama Dinamika Latex (Indonesia, ID) from 1991 to 1999: 11 510(k) clearances. Most are in product codes LYY (Latex Patient Examination Glove) and LZA (Polymer Patient Examination Glove). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided P.T. Irama Dinamika Latex’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for P.T. Irama Dinamika Latex since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — P.T. Irama Dinamika Latex by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like P.T. Irama Dinamika Latex’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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P.T. Irama Dinamika Latex

Which product codes does it file in?

What has FDA decided for it lately?