510(k) Report

FDA applicant

Lon Tai Chemical Industrial Co., Ltd.

Changhua Taiwan 50606, TW3 decisions1989–19900 recalls

FDA records 3 decisions for Lon Tai Chemical Industrial Co., Ltd. (Changhua Taiwan 50606, TW) from 1989 to 1990: 3 510(k) clearances. Most are in product codes LYY (Latex Patient Examination Glove) and KGO (Surgeon'S Gloves). 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 Lon Tai Chemical Industrial Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Lon Tai Chemical Industrial Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Lon Tai Chemical Industrial Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report