510(k) Report

FDA applicant

Tak Ent., Inc.

Walnut, CA4 decisions1989–19890 recalls

FDA records 4 decisions for Tak Ent., Inc. (Walnut, CA) in 1989: 4 510(k) clearances. Most are in product codes LYZ (Vinyl Patient Examination Glove) and LYY (Latex 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 Tak Ent., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Tak Ent., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Tak Ent., 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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