510(k) Report

FDA applicant

Great Glove (Thailand) Co., Ltd.

A. Thalang, Phuket, TH2 decisions2001–20020 recalls

FDA records 2 decisions for Great Glove (Thailand) Co., Ltd. (A. Thalang, Phuket, TH) from 2001 to 2002: 2 510(k) clearances. 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 Great Glove (Thailand) Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Great Glove (Thailand) Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Great”

FDA records each applicant name separately; these may or may not be the same firm.