510(k) Report

FDA applicant

Medigloves, Ltd.

Pathumtani, TH6 decisions1989–20050 recalls

FDA records 6 decisions for Medigloves, Ltd. (Pathumtani, TH) from 1989 to 2005: 6 510(k) clearances. Most are in product codes LYY (Latex Patient Examination Glove) and KGO (Surgeon'S Gloves). Its devices cite 3 predicates, 0 of them its own earlier devices. 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 Medigloves, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medigloves, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Medigloves, Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Medigloves, 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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