510(k) Report

FDA applicant

C & K Mfg. & Sales Co.

West Lake, OH3 decisions1989–19890 recalls

FDA records 3 decisions for C & K Mfg. & Sales Co. (West Lake, OH) in 1989: 3 510(k) clearances. Most are in product codes LYY (Latex Patient Examination Glove) and 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 C & K Mfg. & Sales Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for C & K Mfg. & Sales Co. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — C & K Mfg. & Sales Co. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like C & K Mfg. & Sales Co.’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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