FDA applicant
Dongkuk Techco Rubber Industries
FDA records 2 decisions for Dongkuk Techco Rubber Industries (Penang, MY) from 1986 to 2000: 2 510(k) clearances. All are in product code HIS (Condom). 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 Dongkuk Techco Rubber Industries’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Dongkuk Techco Rubber Industries since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Dongkuk Techco Rubber Industries’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) ReportOther applicant names beginning “Dongkuk”
FDA records each applicant name separately; these may or may not be the same firm.