FDA applicant
Hankook Latex Gongup Co., Ltd.
FDA records 2 decisions for Hankook Latex Gongup Co., Ltd. (Chuncheon-Si, KR) from 1990 to 2015: 2 510(k) clearances. All are in product code HIS (Condom). 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 Hankook Latex Gongup Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2015
2007high 1 (2015) · low 0 (2007)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Hankook Latex Gongup Co., Ltd.’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