Cleared Abbreviated

K053367 - MALE NATURAL RUBBER LATEX CONDOM

K053367 is an FDA 510(k) clearance for MALE NATURAL RUBBER LATEX 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 78-day FDA review.

K053367 · Innolatex Sdn. Bhd · Obstetrics & Gynecology device
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Feb 2006
Decision
78d
Days
Class 2
Risk

K053367 is an FDA 510(k) clearance for the MALE NATURAL RUBBER LATEX CONDOM. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Innolatex Sdn. Bhd (Selangor Darul Ehsan, MY). The FDA issued a Cleared decision on February 21, 2006 after a review of 78 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.

FDA 510(k) Submission Details - K053367

510(k) Number K053367 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2005
Decision Date February 21, 2006
Days to Decision 78 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
83d faster than avg
Panel avg: 161d · This submission: 78d
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 396
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K053367.
GREEN LOVE MALE CONTRACEPTIVE (CONDOM)
K051842 · Cupid Condom, Ltd. · Apr 2006
NAKED
K060797 · Veraxis Int'L, Inc. · Apr 2006
DICK'S FORMALWEAR MALE LATEX CONDOM
K050913 · Dick'S Formalwear, Inc. · Apr 2006
VIELLE LUBRICANT
K051288 · Cst Medical Limited · Feb 2006
DUREX MALE COLORED LATEX CONDOMS WITH SCENTED LUBRICANTS
K052959 · Ssl Americas · Jan 2006
DIVAS DUAL PLEASURE MALE LATEX CONDOM
K051273 · Eagle Twe, Inc. · Aug 2005
K053367 · MALE NATURAL RUBBER LATEX CONDOM
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