Cleared Abbreviated

K132107 - MALE LATEX CONDOM

K132107 is an FDA 510(k) clearance for MALE LATEX CONDOM, manufactured by Nulatex Sdn. Bhd.. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Abbreviated 510(k) pathway after a 242-day FDA review.

K132107 · Nulatex Sdn. Bhd. · Obstetrics & Gynecology device
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Mar 2014
Decision
242d
Days
Class 2
Risk

K132107 is an FDA 510(k) clearance for the MALE LATEX CONDOM. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Nulatex Sdn. Bhd. (Kluang, Johor, MY). The FDA issued a Cleared decision on March 7, 2014 after a review of 242 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.

FDA 510(k) Submission Details - K132107

510(k) Number K132107 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 2013
Decision Date March 07, 2014
Days to Decision 242 days
Submission Type Abbreviated
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d slower than avg
Panel avg: 161d · This submission: 242d
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 357
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K132107.
MEGA BIG BOY CONDOM
K140379 · Okamoto USA, Inc. · Jul 2014
SUSTAIN
K131866 · Hollender Sustainable Brands, LLC · May 2014
INSTINCT
K132390 · Profilatex, S.A. DE C.V. · Apr 2014
BLACK COLOURED CONDOM
K132597 · Karex Industries Sdn. Bhd. · Nov 2013
TROJAN JAGUAR MALE NATURAL RUBBER LATEX CONDOM WITH WARMING AND TINGLING LUBRICANT
K131887 · Church & Dwight Co., Inc. · Oct 2013
THEYFIT MALE CONDOM
K122219 · Theyfit · Sep 2013
K132107 · MALE LATEX CONDOM
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