Cleared Traditional

K250034 - Natural rubber latex male condom

K250034 is an FDA 510(k) clearance for Natural rubber latex male condom, manufactured by Shaoguan Regenex Pharmaceuticals Co., Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Traditional 510(k) pathway after a 185-day FDA review.

K250034 · Shaoguan Regenex Pharmaceuticals Co., Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2025
Decision
185d
Days
Class 2
Risk

K250034 is an FDA 510(k) clearance for the Natural rubber latex male condom. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Shaoguan Regenex Pharmaceuticals Co., Ltd. (Shaoguan, CN). The FDA issued a Cleared decision on July 11, 2025 after a review of 185 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5300 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Shaoguan Regenex Pharmaceuticals Co., Ltd. devices

FDA 510(k) Submission Details - K250034

510(k) Number K250034 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 160d · This submission: 185d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HIS Device Classification - Class 2, Special Controls

Product Code HIS Condom
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Consultant

Shanghai SUNGO Management Consulting Co., Ltd.
Luna Hu

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HIS Condom

All 59
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K250034.
Male Latex Condom HA
K252622 · Okamoto USA, Inc. · May 2026
LifeStyles® HydraFeel Natural Rubber Latex Condom
K252521 · Suretex Limited · Nov 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