510(k) Report

FDA applicant

Universal Gloves Corp.

Taiwan, R.O.C., TW3 decisions1989–19980 recalls

FDA records 3 decisions for Universal Gloves Corp. (Taiwan, R.O.C., TW) from 1989 to 1998: 3 510(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 Universal Gloves Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Universal Gloves Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Universal Gloves Corp.’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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