510(k) Report

FDA applicant

Ku Shing Industries Sdn. Bhd.

Est. Prai Penang, MY1 decision1989–19890 recalls

FDA records 1 decision for Ku Shing Industries Sdn. Bhd. (Est. Prai Penang, MY) in 1989: 1 510(k) clearance. All are in product code 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 Ku Shing Industries Sdn. Bhd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ku Shing Industries Sdn. Bhd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Ku Shing Industries Sdn. Bhd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ku Shing Industries Sdn. Bhd.’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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