Cleared Traditional

Durex Penck III Regular

K222068 · Rb Health (Us), LLC · Obstetrics & Gynecology
Oct 2022
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K222068 is an FDA 510(k) clearance for the Durex Penck III Regular, a Condom (Class II — Special Controls, product code HIS), submitted by Rb Health (Us), LLC (Parsippany, US). The FDA issued a Cleared decision on October 12, 2022, 90 days after receiving the submission on July 14, 2022. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5300.

Submission Details

510(k) Number K222068 FDA.gov
FDA Decision Cleared SESE
Date Received July 14, 2022
Decision Date October 12, 2022
Days to Decision 90 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