The following data is part of a premarket notification filed by Thai Nippon Rubber Industry Public Company Limited with the FDA for One Touch Spiral Condom.
| Device ID | K210294 |
| 510k Number | K210294 |
| Device Name: | One Touch Spiral Condom |
| Classification | Condom |
| Applicant | Thai Nippon Rubber Industry Public Company Limited 789/139 Pinthong Industrial Estate Nongkham Sriracha, TH 20230 |
| Contact | Ryosuke Takamiya |
| Correspondent | Kevin Walls Regulatory Insight, Inc. 33 Golden Eagle Lane Littleton, CO 80127 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-02 |
| Decision Date | 2021-09-23 |