Cleared Traditional

TROJAN(TM) Her Pleasure Warming male natural rubber latex condom with warming lubricant

K221431 · Church & Dwight Co., Inc. · Obstetrics & Gynecology
Jul 2022
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K221431 is an FDA 510(k) clearance for the TROJAN(TM) Her Pleasure Warming male natural rubber latex condom with warming lubricant, a Condom (Class II — Special Controls, product code HIS), submitted by Church & Dwight Co., Inc. (Ewing, US). The FDA issued a Cleared decision on July 14, 2022, 58 days after receiving the submission on May 17, 2022. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5300.

Submission Details

510(k) Number K221431 FDA.gov
FDA Decision Cleared SESE
Date Received May 17, 2022
Decision Date July 14, 2022
Days to Decision 58 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code HIS — Condom
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.5300

Similar Devices — HIS Condom

All 399
LifeStyles? HydraFeel Natural Rubber Latex Condom
K252521 · Suretex Limited · Nov 2025
Natural rubber latex male condom
K250034 · Shaoguan Regenex Pharmaceuticals Co., Ltd. · Jul 2025
Lelo Hex Lubricated Natural Rubber Latex Condom
K243421 · Lelo, Inc. · Mar 2025
Trojan? Ultra Ribbed Ecstasy latex condom with lubricant (Trojan? Ultra Ribbed Ecstasy)
K243640 · Church & Dwight Co., Inc. · Feb 2025
0.04 ZERO ZERO FOUR Male Latex Condom
K243584 · Okamoto USA, Inc. · Feb 2025
LifeStyles NRL Textured Condom
K232279 · Suretex Limited · Oct 2023