Cleared Traditional

K162919 - Male Latex Condoms

K162919 is an FDA 510(k) clearance for Male Latex Condoms, manufactured by Zhejiang Xiangban Latex Products Co., Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K162919 · Zhejiang Xiangban Latex Products Co., Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2017
Decision
140d
Days
Class 2
Risk

K162919 is an FDA 510(k) clearance for the Male Latex Condoms. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Zhejiang Xiangban Latex Products Co., Ltd. (Yiwu, CN). The FDA issued a Cleared decision on March 7, 2017 after a review of 140 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K162919

510(k) Number K162919 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2016
Decision Date March 07, 2017
Days to Decision 140 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 161d · This submission: 140d
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

Medwheat (Shanghai) Medical Technology Co. , Ltd.
Jonathan 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 351
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K162919.
Trojan Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant
K180104 · Church & Dwight Co., Inc. · Mar 2018
One Touch Condom with Benzocaine
K171213 · Thai Nippon Rubber Industry Public Company Limited. · Jan 2018
JUD custom fit condom
K172414 · Global Mailer Partners, LLC · Oct 2017
Lifestyles Zero Lubricated Latex Male Condom
K163107 · Ansell Healthcare Products, LLC · Jan 2017
LELO RESPECT HEX Natural Rubber Latex Condom
K162511 · Lelo, Inc. · Jan 2017
aoni Natural Rubber Latex Condom
K153016 · Guangzhou Daming United Rubber Products , Ltd. · Oct 2016
K162919 · Male Latex Condoms
Download PDF FDA Summary Zhejiang Xiangban Lat…