Cleared Abbreviated

K062730 - NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOMS

K062730 is an FDA 510(k) clearance for NON-SPERMICIDAL LUBRICATED MALE LATEX C..., manufactured by Biogreen Medical Sdn. Bhd.. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Abbreviated 510(k) pathway after a 22-day FDA review.

K062730 · Biogreen Medical Sdn. Bhd. · Obstetrics & Gynecology device
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Oct 2006
Decision
22d
Days
Class 2
Risk

K062730 is an FDA 510(k) clearance for the NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOMS. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Biogreen Medical Sdn. Bhd. (Ipoh, Perak, MY). The FDA issued a Cleared decision on October 5, 2006 after a review of 22 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 - K062730

510(k) Number K062730 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2006
Decision Date October 05, 2006
Days to Decision 22 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
139d faster than avg
Panel avg: 161d · This submission: 22d
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 K062730.
TROJAN THINTENSITY BRAND MALE LATEX CONDOM
K071272 · Church & Dwight Co., Inc. · Sep 2007
MALE NATURAL RUBBER LATEX CONDOM (WITH COLORING AND FLAVORING)
K070830 · Karex Industries Sdn. Bhd. · May 2007
BANANA RIBBED
K063401 · Medtech Products , Ltd. · Mar 2007
ZEUS MALE CONDOM APPLICATOR
K052206 · Condax, LLC · Sep 2006
GREEN LOVE MALE CONTRACEPTIVE (CONDOM)
K051842 · Cupid Condom, Ltd. · Apr 2006
NAKED
K060797 · Veraxis Int'L, Inc. · Apr 2006
K062730 · NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOMS
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