Cleared Abbreviated

K072169 - DUREX SYNTHETIC POLYISOPRENE MALE CONDOM

K072169 is an FDA 510(k) clearance for DUREX SYNTHETIC POLYISOPRENE MALE CONDOM, manufactured by Ssl Americas, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code MOL cleared through the Abbreviated 510(k) pathway after a 318-day FDA review.

K072169 · Ssl Americas, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2008
Decision
318d
Days
Class 2
Risk

K072169 is an FDA 510(k) clearance for the DUREX SYNTHETIC POLYISOPRENE MALE CONDOM. Classified as Condom, Synthetic (product code MOL), Class II - Special Controls.

Submitted by Ssl Americas, Inc. (Norcross, US). The FDA issued a Cleared decision on June 19, 2008 after a review of 318 days - an unusually long review period, suggesting complex equivalence evaluation.

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 Ssl Americas, Inc. devices

FDA 510(k) Submission Details - K072169

510(k) Number K072169 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2007
Decision Date June 19, 2008
Days to Decision 318 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
158d slower than avg
Panel avg: 160d · This submission: 318d
Pathway characteristics
Standards-based clearance path.

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 20
Devices cleared under the same product code (MOL) and FDA review panel - the closest regulatory comparables to K072169.
Trojan Supra Lubricated Polyurethane Male Condom
K171639 · Church & Dwight Co., Inc. · 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
TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM
K050828 · Church & Dwight Co., Inc. · Feb 2006
EZ-ON CONDOM
K001974 · Mayer Laboratories · Oct 2001