Cleared Special

K113061 - LARGE/EXTRA LAGRE CONDOM

K113061 is an FDA 510(k) clearance for LARGE/EXTRA LAGRE CONDOM, manufactured by Karex Industries Sdn. Bhd.. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Special 510(k) pathway after a 54-day FDA review.

K113061 · Karex Industries Sdn. Bhd. · Obstetrics & Gynecology device
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Dec 2011
Decision
54d
Days
Class 2
Risk

K113061 is an FDA 510(k) clearance for the LARGE/EXTRA LAGRE CONDOM. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Karex Industries Sdn. Bhd. (Johor Darul Takzim, MY). The FDA issued a Cleared decision on December 7, 2011 after a review of 54 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.

View all Karex Industries Sdn. Bhd. devices

FDA 510(k) Submission Details - K113061

510(k) Number K113061 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 2011
Decision Date December 07, 2011
Days to Decision 54 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 160d · This submission: 54d
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 60
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K113061.
TROJAN JAGUAR MALE NATURAL RUBBER LATEX CONDOM WITH WARMING AND TINGLING LUBRICANT
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TROJAN HER PLEASURE (RIBBED) ECSTASY LATEX CONDOM WITH LUBRICANT
K120286 · Church & Dwight Co., Inc. · Jun 2012
TROJAN MAGNUM CONDOM WITH FIRE & ICE LUBRICANT
K120287 · Church & Dwight Co., Inc. · May 2012
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