510(k) Report

FDA applicant

Rosner-Mautby Meditrade (Thailand), Ltd.

Hatyai, Songkhla, TH1 decision2004–20040 recalls

FDA records 1 decision for Rosner-Mautby Meditrade (Thailand), Ltd. (Hatyai, Songkhla, TH) in 2004: 1 510(k) clearance. All are in product code LYY (Latex 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 Rosner-Mautby Meditrade (Thailand), Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Rosner-Mautby Meditrade (Thailand), Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Rosner-Mautby Meditrade (Thailand), Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Rosner-Mautby Meditrade (Thailand), Ltd.’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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