Data / Medical devices / Thailand / Thai Nippon Rubber Industry Public Company Limited
Thai Nippon Rubber Industry Public Company Limited: FDA-registered device maker in Sriracha Chon Buri, Thailand, 14 510(k) clearances
Thai Nippon Rubber Industry Public Company Limited is registered with the FDA (registration 3008808138) in Sriracha Chon Buri, Thailand. It lists 3 device types. The FDA files 14 510(k) clearances under its listings, the newest dated March 7, 2025. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3008808138
- Address
- 789/139 Pinthong Industrial Estate Nongkham, Sriracha Chon Buri, Thailand, 20110
- Owner or operator
- THAI NIPPON RUBBER INDUSTRY PUBLIC COMPANY LIMITED. (9039377)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- October 21, 1999
- Registered through
- 2026
- Brand names listed
- AMPILLAR - G-CON H-WAVE, AMPILLAR - PLAYFUL GIANTS, AMPILLAR - STAY & PLAY PLEASURES, AMPILLAR - ULTRA THIN BERRY DELIGHT, AMPILLAR - ULTRA THIN XL GOLD, B CONDOM - CLASSIC ULTRA LUBE, B CONDOM - PLATINUM LARGE, B CONDOM - PLATINUM XL and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Condom | HIS | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Condom With Nonoxynol-9 | LTZ | 2 | Manufacturer | accessdata.fda.gov |
| Lubricant, Personal | NUC | 2 | 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 |
|---|---|---|---|---|---|---|
| March 7, 2025 | K243421 | Lelo Hex Lubricated Natural Rubber Latex Condom | HIS | Substantially Equivalent | Lelo, Inc. | accessdata.fda.gov |
| October 21, 2022 | K220273 | Onetouch Non-paraben Lubricant Gel | NUC | Substantially Equivalent | Thai Nippon Rubber Industry Public Company Limited. | accessdata.fda.gov |
| November 23, 2021 | K210095 | Playboy Premium Silicone Lubricant | NUC | Substantially Equivalent | Thai Nippon Rubber Industry Public Company Limited. | accessdata.fda.gov |
| September 30, 2021 | K211450 | Playboy 3 Contour Condom | HIS | Substantially Equivalent | Thai Nippon Rubber Industry Public Company Limited. | accessdata.fda.gov |
| September 23, 2021 | K210294 | One Touch Spiral Condom | HIS | Substantially Equivalent | Thai Nippon Rubber Industry Public Company Limited. | accessdata.fda.gov |
| April 15, 2019 | K181844 | One Touch | HIS | Substantially Equivalent | Thai Nippon Rubber Industry Public Company, Ltd. | accessdata.fda.gov |
| January 12, 2018 | K171213 | One Touch Condom with Benzocaine | HIS | Substantially Equivalent | Thai Nippon Rubber Industry Public Company Limited. | accessdata.fda.gov |
| January 13, 2017 | K162511 | LELO RESPECT HEX Natural Rubber Latex Condom | HIS | Substantially Equivalent | Lelo, Inc. | accessdata.fda.gov |
| June 30, 2016 | K160644 | Lelo Hex Natural Rubber Latex Condom | HIS | Substantially Equivalent | Lelo, Inc. | accessdata.fda.gov |
| July 30, 2015 | K142790 | OneTouch Lubricant Gel | NUC | Substantially Equivalent | Thai Nippon Rubber Industry Co., Ltd. | accessdata.fda.gov |
| October 16, 2009 | K081265 | THAI NIPPON MALE LATEX CONDOM | HIS | Substantially Equivalent | Thai Nippon Rubber Industry Co., Ltd. | accessdata.fda.gov |
| December 16, 2003 | K032909 | THAI NIPPON EXTRA STRENGTH MALE LATEX CONDOM | HIS | Substantially Equivalent | Thai Nippon Rubber Industry Co., Ltd. | accessdata.fda.gov |
| August 8, 2000 | K001978 | 'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9 | LTZ | Substantially Equivalent | Thai Nippon Rubber Industry Co., Ltd. | accessdata.fda.gov |
| January 18, 2000 | K994095 | LATEX CONDOM | HIS | Substantially Equivalent | Thai Nippon Rubber Industry Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated March 7, 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.