Cleared Abbreviated

K012964 - 56MM CONDOM,MALE NATURAL RUBBER LATEX CONDOM

K012964 is an FDA 510(k) clearance for 56MM CONDOM, manufactured by Innolatex Sdn. Bhd. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Abbreviated 510(k) pathway after a 66-day FDA review.

K012964 · Innolatex Sdn. Bhd · Obstetrics & Gynecology device
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Nov 2001
Decision
66d
Days
Class 2
Risk

K012964 is an FDA 510(k) clearance for the 56MM CONDOM,MALE NATURAL RUBBER LATEX CONDOM. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Innolatex Sdn. Bhd (Shah Alam, Selangor D.E., MY). The FDA issued a Cleared decision on November 9, 2001 after a review of 66 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 Innolatex Sdn. Bhd devices

FDA 510(k) Submission Details - K012964

510(k) Number K012964 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2001
Decision Date November 09, 2001
Days to Decision 66 days
Submission Type Abbreviated
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 160d · This submission: 66d
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 152
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K012964.
TROJAN THINTENSITY BRAND MALE LATEX CONDOM
K071272 · Church & Dwight Co., Inc. · Sep 2007
ASTROGLIDE BRAND WARMING LIQUID PERSONAL LUBRICANT
K041432 · Biofilm, Inc. · Nov 2004
TROJAN MINT TINGLE BRAND LATEX CONDOMS
K023405 · Armkel, LLC · Dec 2002
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