510(k) Report

FDA applicant

Innovative Gloves Co;, Ltd.

Hatyai, Songkhla, TH9 decisions1999–20110 recalls

FDA records 9 decisions for Innovative Gloves Co;, Ltd. (Hatyai, Songkhla, TH) from 1999 to 2011: 9 510(k) clearances. Most are in product codes LYY (Latex Patient Examination Glove) and LZA (Polymer Patient Examination Glove). Its devices cite 1 predicate, 1 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 Innovative Gloves Co;, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2011

2009: 12011: 2
2007high 2 (2011) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Innovative Gloves Co;, 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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