Cleared Abbreviated

K031369 - MERCATOR HEALTHCARE MALE LATEX CONDOM

K031369 is an FDA 510(k) clearance for MERCATOR HEALTHCARE MALE LATEX CONDOM, manufactured by Mercator Healthcare , Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Abbreviated 510(k) pathway after a 184-day FDA review.

K031369 · Mercator Healthcare , Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
184d
Days
Class 2
Risk

K031369 is an FDA 510(k) clearance for the MERCATOR HEALTHCARE MALE LATEX CONDOM. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Mercator Healthcare , Ltd. (Durham, US). The FDA issued a Cleared decision on October 31, 2003 after a review of 184 days - an extended review 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 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 Mercator Healthcare , Ltd. devices

FDA 510(k) Submission Details - K031369

510(k) Number K031369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2003
Decision Date October 31, 2003
Days to Decision 184 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
24d slower than avg
Panel avg: 160d · This submission: 184d
Pathway characteristics
Standards-based clearance path.

HIS Device Classification - Class 2, Special Controls

Product Code HIS Condom
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 - HIS Condom

All 60
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K031369.
TROJAN THINTENSITY BRAND MALE LATEX CONDOM LUBRICATED WITH ULTRASMOOTH AND WARM SENSATIONS LUBRICANT
K073016 · Church & Dwight Co., Inc. · Nov 2007
TROJAN-ENZ BRAND
K071313 · Church & Dwight Co., Inc. · Oct 2007
TROJAN THINTENSITY BRAND MALE LATEX CONDOM
K071272 · Church & Dwight Co., Inc. · Sep 2007
TROJAN MINT TINGLE BRAND LATEX CONDOMS
K023405 · Armkel, LLC · Dec 2002
TROJAN EXTRA LARGE LATEX CONDOM
K001212 · Armkel, LLC · May 2000
TROJAN LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT
K000748 · Armkel, LLC · Apr 2000