Cleared Abbreviated

K023405 - TROJAN MINT TINGLE BRAND LATEX CONDOMS

K023405 is an FDA 510(k) clearance for TROJAN MINT TINGLE BRAND LATEX CONDOMS, manufactured by Armkel, LLC. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Abbreviated 510(k) pathway after a 67-day FDA review.

K023405 · Armkel, LLC · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2002
Decision
67d
Days
Class 2
Risk

K023405 is an FDA 510(k) clearance for the TROJAN MINT TINGLE BRAND LATEX CONDOMS. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Armkel, LLC (Princeton, US). The FDA issued a Cleared decision on December 16, 2002 after a review of 67 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 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 Armkel, LLC devices

FDA 510(k) Submission Details - K023405

510(k) Number K023405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 2002
Decision Date December 16, 2002
Days to Decision 67 days
Submission Type Abbreviated
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
93d faster than avg
Panel avg: 160d · This submission: 67d
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 189
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K023405.
POWERSTICK MALE LATEX CONDOMS
K041717 · A.P.Deauville, LLC · Jan 2005
ASTROGLIDE BRAND WARMING LIQUID PERSONAL LUBRICANT
K041432 · Biofilm, Inc. · Nov 2004
INNOLATEX MALE LATEX CONDOMS COLORED AND SCENTED
K041837 · Innolatex Sdn. Bhd · Sep 2004
REMED MALE TUTTI FRUTTI CONDOM (BANANA), PREVENTOR, LUCKY BOY, SUMMIT
K993389 · Remed Pharma · Aug 2000
REMED MALE TUTTI FRUTTI CONDOM (STRAWBERRY) PREVENTOR, LUCKY BOY, SUMMIT
K993403 · Remed Pharma · Aug 2000
REMED MALE TUTTI FRUTTI CONDOM (COCONUT) PREVENTOR, LUCKY BOY, SUMMIT
K993409 · Remed Pharma · Aug 2000