FDA applicant
Megine Industries Sdn Bhd
FDA records 2 decisions for Megine Industries Sdn Bhd (Kuala Lumpur, MY) from 2021 to 2022: 2 510(k) clearances. All are in product code LZA (Polymer Patient Examination Glove). Its devices cite 1 predicate, 0 of them its own earlier devices. 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 Megine Industries Sdn Bhd’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2021.
Planning a device like Megine 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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