Cleared Abbreviated

K163107 - Lifestyles Zero Lubricated Latex Male Condom

K163107 is an FDA 510(k) clearance for Lifestyles Zero Lubricated Latex Male C..., manufactured by Ansell Healthcare Products, LLC. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Abbreviated 510(k) pathway after a 77-day FDA review.

K163107 · Ansell Healthcare Products, LLC · Obstetrics & Gynecology device
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Jan 2017
Decision
77d
Days
Class 2
Risk

K163107 is an FDA 510(k) clearance for the Lifestyles Zero Lubricated Latex Male Condom. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Ansell Healthcare Products, LLC (Iselin, US). The FDA issued a Cleared decision on January 23, 2017 after a review of 77 days - a notably fast clearance 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Ansell Healthcare Products, LLC devices

FDA 510(k) Submission Details - K163107

510(k) Number K163107 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2016
Decision Date January 23, 2017
Days to Decision 77 days
Submission Type Abbreviated
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
83d faster than avg
Panel avg: 160d · This submission: 77d
Pathway characteristics
Standards-based clearance path.

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 Peers - HIS Condom

All 186
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K163107.
One Touch Condom with Benzocaine
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aoni Natural Rubber Latex Condom
K153016 · Guangzhou Daming United Rubber Products , Ltd. · Oct 2016
Trojan XOXO Ribbed Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant
K161915 · Church & Dwight Co., Inc. · Sep 2016