Cleared Traditional

K100767 - TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM

K100767 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 383-day FDA review.

K100767 · Church & Dwight Co., Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2011
Decision
383d
Days
Class 2
Risk

K100767 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. (Princeton, US). The FDA issued a Cleared decision on April 5, 2011 after a review of 383 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 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. Elevated predicate reliance profile. 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 Church & Dwight Co., Inc. devices

FDA 510(k) Submission Details - K100767

510(k) Number K100767 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2010
Decision Date April 05, 2011
Days to Decision 383 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
223d slower than avg
Panel avg: 160d · This submission: 383d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. 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 K100767.
Skyn Original Polyisoprene Lubricated Male Condom - Flavored
K171172 · Ansell Healthcare Products, LLC · Aug 2017
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
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