Cleared Traditional

Natural rubber latex male condom

K250034 · Shaoguan Regenex Pharmaceuticals Co., Ltd. · Obstetrics & Gynecology
Jul 2025
Decision
185d
Days
Class 2
Risk

About This 510(k) Submission

K250034 is an FDA 510(k) clearance for the Natural rubber latex male condom, a Condom (Class II — Special Controls, product code HIS), submitted by Shaoguan Regenex Pharmaceuticals Co., Ltd. (Shaoguan, CN). The FDA issued a Cleared decision on July 11, 2025, 185 days after receiving the submission on January 7, 2025. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5300.

Submission Details

510(k) Number K250034 FDA.gov
FDA Decision Cleared SESE
Date Received January 07, 2025
Decision Date July 11, 2025
Days to Decision 185 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement

Device Classification

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

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