510(k) Report

FDA applicant

One Touch Products Co., Ltd.

Rancho Cucamonga, CA1 decision2004–20040 recalls

FDA records 1 decision for One Touch Products Co., Ltd. (Rancho Cucamonga, CA) in 2004: 1 510(k) clearance. 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 One Touch Products Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for One Touch Products Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like One Touch Products 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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