Cleared Traditional

K162919 - Male Latex Condoms (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K162919 · Zhejiang Xiangban Latex Products Co., Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
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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.

View all Zhejiang Xiangban Latex Products Co., Ltd. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 160d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Peers - HIS Condom

All 399
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