The following data is part of a premarket notification filed by Church & Dwight Co., Inc. with the FDA for Trojan(tm) Her Pleasure Warming Male Natural Rubber Latex Condom With Warming Lubricant.
| Device ID | K221431 |
| 510k Number | K221431 |
| Device Name: | TROJAN(TM) Her Pleasure Warming Male Natural Rubber Latex Condom With Warming Lubricant |
| Classification | Condom |
| Applicant | Church & Dwight Co., Inc. 500 Charles Ewing Blvd. Ewing, NJ 08628 |
| Contact | Supreet Sahota-Bhatti |
| Correspondent | Dawn Reilly-O'Dell Full Circle Regulatory Consulting, LLC 107 Casablanca Court Cary, NC 27519 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-17 |
| Decision Date | 2022-07-14 |