510(k) Report

FDA applicant

Kingswell International, Inc.

Walnut, CA3 decisions2003–20030 recalls

FDA records 3 decisions for Kingswell International, Inc. (Walnut, CA) in 2003: 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 Kingswell International, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Kingswell International, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Kingswell International, Inc.’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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