FDA applicant
Pt. Intan Hevea Industry
FDA records 2 decisions for Pt. Intan Hevea Industry (Medan - Indonesia, ID) from 1989 to 2011: 2 510(k) clearances. All are in product code LYY (Latex Patient Examination Glove). Its devices cite 1 predicate, 1 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 Pt. Intan Hevea Industry’s devices, and how often a recall has named them.
FDA decisions per year
1in 2011
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
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