Cleared Abbreviated

K082529 - ALATECH CHAMPION VYTEX LUBRICATED MALE LATEX CONDOM

K082529 is an FDA 510(k) clearance for ALATECH CHAMPION VYTEX LUBRICATED MALE ..., manufactured by Alatech Healthcare, LLC. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Abbreviated 510(k) pathway after a 241-day FDA review.

K082529 · Alatech Healthcare, LLC · Obstetrics & Gynecology device
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May 2009
Decision
241d
Days
Class 2
Risk

K082529 is an FDA 510(k) clearance for the ALATECH CHAMPION VYTEX LUBRICATED MALE LATEX CONDOM. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Alatech Healthcare, LLC (Eufaula, US). The FDA issued a Cleared decision on May 1, 2009 after a review of 241 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.

View all Alatech Healthcare, LLC devices

FDA 510(k) Submission Details - K082529

510(k) Number K082529 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 2008
Decision Date May 01, 2009
Days to Decision 241 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
80d slower than avg
Panel avg: 161d · This submission: 241d
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 252
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K082529.
MALE LATEX CONDOM (STRAIGHT SIDE OR CONTOURED OR FLARED IN SHAPE, EITHER TEXTURED OR NON-TEXTURED , LUBRICATED OR NON-LU
K092586 · Innolatex (Thailand) Limited · May 2010
THAI NIPPON MALE LATEX CONDOM
K081265 · Thai Nippon Rubber Industry Co., Ltd. · Oct 2009
M. DIOR BRAND
K083817 · Suzhou Colour-Way Enterprise Development Co., Ltd. · Sep 2009
OKAMOTO ULTRA THIN
K090259 · Okamoto USA, Inc. · Mar 2009
KAREX INDUSTRIES MALE NATURAL RUBBER LATEX CONDOM, NON-SPERMICIDAL, LUBRICATED AND NON LUBRICATED
K081886 · Karex Industries Sdn. Bhd. · Feb 2009
TWINLOTUS AND SHIELDS NATURAL RUBBER LATEX CONDOM
K081413 · Dailian Latex Company, Ltd. · Oct 2008