510(k) Report

FDA applicant

General Gloves Corp.

Tainan Hsien, TW6 decisions1998–20030 recalls

FDA records 6 decisions for General Gloves Corp. (Tainan Hsien, TW) from 1998 to 2003: 6 510(k) clearances. All are in product code LYZ (Vinyl 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 General Gloves Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for General Gloves Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like General Gloves Corp.’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