Cleared Special

K001212 - TROJAN EXTRA LARGE LATEX CONDOM

K001212 is an FDA 510(k) clearance for TROJAN EXTRA LARGE LATEX CONDOM, manufactured by Armkel, LLC. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Special 510(k) pathway after a 25-day FDA review.

K001212 · Armkel, LLC · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2000
Decision
25d
Days
Class 2
Risk

K001212 is an FDA 510(k) clearance for the TROJAN EXTRA LARGE LATEX CONDOM. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Armkel, LLC (Cranbury, US). The FDA issued a Cleared decision on May 9, 2000 after a review of 25 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K001212

510(k) Number K001212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2000
Decision Date May 09, 2000
Days to Decision 25 days
Submission Type Special
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
136d faster than avg
Panel avg: 161d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

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 401
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K001212.
OSMANTHUS, KONGFU, AND GOBON, NATURAL RUBBER LATEX CONDOMS
K994118 · Guilin Latex Factory · Aug 2000
LIFESTYLES, CONTEMPO OR PRIVATE LABEL LARGE CONDOM
K001883 · Ansell Healthcare, Inc. · Jul 2000
MALE LATEX COMDOM WITH DOTTED SURFACE
K001221 · Pleasure Latex Products Sdn. Bhd. · May 2000
LIFESTYLES, CONTEMPO OR PRIVATE LABEL STRAWBERRY, VANILLA, OR BANANA FLAVORED CONDOM
K000408 · Suretex Prophylactics , Ltd. · Apr 2000
TROJAN LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT
K000748 · Armkel, LLC · Apr 2000
INVIGRA MALE LATEX CONDOM GREEN COLORED AND MINT FLAVORED
K000038 · Indus Medicare , Ltd. · Mar 2000
K001212 · TROJAN EXTRA LARGE LATEX CONDOM
Download PDF FDA Summary Armkel, LLC