Cleared Abbreviated

K171172 - Skyn Original Polyisoprene Lubricated Male Condom - Flavored (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K171172 · Ansell Healthcare Products, LLC · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2017
Decision
103d
Days
Class 2
Risk

K171172 is an FDA 510(k) clearance for the Skyn Original Polyisoprene Lubricated Male Condom - Flavored. Classified as Condom, Synthetic (product code MOL), Class II - Special Controls.

Submitted by Ansell Healthcare Products, LLC (Iselin, US). The FDA issued a Cleared decision on August 2, 2017 after a review of 103 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 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

Submission Details

510(k) Number K171172 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2017
Decision Date August 02, 2017
Days to Decision 103 days
Submission Type Abbreviated
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 160d · This submission: 103d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code MOL Condom, Synthetic
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 - MOL Condom, Synthetic

All 21
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