Hankook Latex Gongup Co., Ltd.
South KoreaFDA applicant, unverified FDA FEI 3002260664
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Hankook Latex Gongup Co., Ltd. makes
Hankook Latex Gongup Co., Ltd. manufactures latex condoms, including a non-colored variant, as well as a product called Banana Gold, which appears to be a flavored or specialty condom.
The company’s portfolio is regulated under FDA’s Class II device classification and requires 510(k) clearance. These products are listed in the FDA’s 510(k) database.
Catalogue
Banana Gold Ref K150857
Regimes: 510(k) Registry: 510(k)Rubber Condom (Non-Colored) Ref K896987
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3002260664
- Address
- 61, SAKJU-RO 145 BEON-GIL,, CHUNCHEON-SI Gangwon
Frequently asked questions
How many devices does Hankook Latex Gongup Co., Ltd. have in the registry?
The registry currently lists 2 devices for Hankook Latex Gongup Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hankook Latex Gongup Co., Ltd.'s devices?
Among its 2 most recently registered devices, Hankook Latex Gongup Co., Ltd. has devices listed in FDA 510(k) (2 devices).
What risk classes do Hankook Latex Gongup Co., Ltd.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Hankook Latex Gongup Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Hankook Latex Gongup Co., Ltd. in the registry?
The most recently registered devices listed for Hankook Latex Gongup Co., Ltd. include Banana Gold and RUBBER CONDOM (NON-COLORED).