Cleared Traditional

K171639 - Trojan Supra Lubricated Polyurethane Male Condom

K171639 is an FDA 510(k) clearance for Trojan Supra Lubricated Polyurethane Ma..., manufactured by Church & Dwight Co., Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code MOL cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K171639 · Church & Dwight Co., Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
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Aug 2017
Decision
60d
Days
Class 2
Risk

K171639 is an FDA 510(k) clearance for the Trojan Supra Lubricated Polyurethane Male Condom. Classified as Condom, Synthetic (product code MOL), Class II - Special Controls.

Submitted by Church & Dwight Co., Inc. (Ewing, US). The FDA issued a Cleared decision on August 1, 2017 after a review of 60 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Church & Dwight Co., Inc. devices

FDA 510(k) Submission Details - K171639

510(k) Number K171639 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2017
Decision Date August 01, 2017
Days to Decision 60 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
100d faster than avg
Panel avg: 160d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MOL Device Classification - Class 2, Special Controls

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 19
Devices cleared under the same product code (MOL) and FDA review panel - the closest regulatory comparables to K171639.
Okamoto 002 Lubricated Polyurethane Male Condom
K203541 · Okamoto USA, Inc. · Feb 2022
Synthetic Polyisoprene Lubricated Male Condom - 5 senses
K182438 · Sxwell USA, LLC · Dec 2018
Skyn Original Polyisoprene Lubricated Male Condom - Flavored
K171172 · Ansell Healthcare Products, LLC · Aug 2017
Skyn Original Polyisoprene Lubricated Male Condom
K160399 · Ansell Healthcare Products, LLC · Jul 2016
TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM
K100767 · Church & Dwight Co., Inc. · Apr 2011
LIFESTYLES LUBRICATED POLYISOPRENE LATEX MALE CONDOM
K070800 · Ansell Healthcare Products, LLC · Mar 2008