510(k) Report

FDA applicant

Formosa Glove Industrial Co., Ltd.

Westfield, NJ3 decisions1999–20020 recalls

FDA records 3 decisions for Formosa Glove Industrial Co., Ltd. (Westfield, NJ) from 1999 to 2002: 3 510(k) clearances. All are in product code LZA (Polymer 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 Formosa Glove Industrial Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Formosa Glove Industrial Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Formosa Glove 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.

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Other applicant names beginning “Formosa”

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