FDA applicant
Pt. Wrp Buana Multicorpora
FDA records 6 decisions for Pt. Wrp Buana Multicorpora (Medan, ID) from 2000 to 2003: 6 510(k) clearances. Most are in product codes LYY (Latex Patient Examination Glove) and 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 Pt. Wrp Buana Multicorpora’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Pt. Wrp Buana Multicorpora since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Pt. Wrp Buana Multicorpora’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report