Cleared Traditional

K050828 - TROJAN SUPRA LUBRICATED POLYURETHANE MA...

K050828 is the FDA 510(k) clearance for TROJAN SUPRA LUBRICATED POLYURETHANE MA... by Church & Dwight Co., Inc.. It is a Class 2 Obstetrics & Gynecology device (product code MOL) cleared through the Traditional 510(k) pathway after a 333-day FDA review.

K050828 · Church & Dwight Co., Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2006
Decision
333d
Days
Class 2
Risk

K050828 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 February 28, 2006 after a review of 333 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

Submission Details

510(k) Number K050828 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2005
Decision Date February 28, 2006
Days to Decision 333 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
173d slower than avg
Panel avg: 160d · This submission: 333d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.