Data / Medical devices / Thailand / Okamoto Rubber Products Co., Ltd.
Okamoto Rubber Products Co., Ltd.: FDA-registered device maker in PATHUMTHANI Pathum Thani, Thailand, 4 510(k) clearances
Okamoto Rubber Products Co., Ltd. is registered with the FDA (registration 9610410) in PATHUMTHANI Pathum Thani, Thailand. It lists 1 device type. The FDA files 4 510(k) clearances under its listings, the newest dated February 18, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9610410
- FEI number
- 3002806673
- Address
- 60/50, 60/51 Moo 19, NAVANAKORN IND. ESTATE ZONE 2, KLONGLUANG, PATHUMTHANI Pathum Thani, Thailand, 12120
- Owner or operator
- OKAMOTO RUBBER PRODUCTS CO., LTD. (9063116)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- November 7, 2007
- Registered through
- 2026
- Brand names listed
- Crown Condom, WINK CLOSER, WINK Studded, WINK X-large
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Condom | HIS | 2 | Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| February 18, 2025 | K243584 | 0.04 ZERO ZERO FOUR Male Latex Condom | HIS | Substantially Equivalent | Okamoto USA, Inc. | accessdata.fda.gov |
| July 23, 2014 | K141256 | OKAMOTO STUDDED CONDOM | HIS | Substantially Equivalent | Okamoto USA, Inc. | accessdata.fda.gov |
| July 1, 2014 | K140379 | MEGA BIG BOY CONDOM | HIS | Substantially Equivalent | Okamoto USA, Inc. | accessdata.fda.gov |
| May 4, 1990 | K893039 | CONDOM (RUBBER) CONTRACEPTIVE | HIS | Substantially Equivalent | Chinteik Hygiene Products Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated February 18, 2025. 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.