The following data is part of a premarket notification filed by Thai Nippon Rubber Industry Public Company Limited. with the FDA for Onetouch Non-paraben Lubricant Gel.
| Device ID | K220273 |
| 510k Number | K220273 |
| Device Name: | Onetouch Non-paraben Lubricant Gel |
| Classification | Lubricant, Personal |
| Applicant | Thai Nippon Rubber Industry Public Company Limited. 789/139 Pinthong Industrial Estate Nongkham Sriracha, TH 20230 |
| Contact | Tossaporn Nilkhamhang |
| Correspondent | Tossaporn Nilkhamhang Thai Nippon Rubber Industry Public Company Limited. 789/139 Pinthong Industrial Estate Nongkham Sriracha, TH 20230 |
| Product Code | NUC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-31 |
| Decision Date | 2022-10-21 |