Data / Medical devices / South Korea / Hankook Latex Gongup Co., Ltd.
Hankook Latex Gongup Co., Ltd.: FDA-registered device maker in CHUNCHEON-SI Gangwon, South Korea, 2 510(k) clearances
Hankook Latex Gongup Co., Ltd. is registered with the FDA (registration 8040211) in CHUNCHEON-SI Gangwon, South Korea. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated August 14, 2015. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 8040211
- FEI number
- 3002260664
- Address
- 61, Sakju-Ro 145 Beon-Gil, CHUNCHEON-SI Gangwon, South Korea, 200-160
- Owner or operator
- HANKOOK LATEX GONGUP CO., LTD. (8040211)
- Roles
- Contract manufacturer, Foreign private label distributor, Manufacturer
- First device listed
- November 15, 2007
- Registered through
- 2027
- Brand names listed
- CONDOMS
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Condom | HIS | 2 | Contract manufacturer, Foreign private label distributor, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 14, 2015 | K150857 | Banana Gold | HIS | Substantially Equivalent | Hankook Latex Gongup Co., Ltd. | accessdata.fda.gov |
| June 6, 1990 | K896987 | RUBBER CONDOM (NON-COLORED) | HIS | Substantially Equivalent | Hankook Latex Gongup Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated August 14, 2015. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.