FDA applicant
Ganz Industries Sdn. Bhd.
FDA records 4 decisions for Ganz Industries Sdn. Bhd. (Nilai 71800, Negeri Sembilan, MY) from 1995 to 1996: 4 510(k) clearances. Most are in product codes LYY (Latex Patient Examination Glove) and KGO (Surgeon'S Gloves). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Ganz Industries Sdn. Bhd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Ganz Industries Sdn. Bhd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Ganz 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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