Cleared Abbreviated

NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOMS (K062730) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

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.

View all Biogreen Medical Sdn. Bhd. devices

Submission Details

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
138d faster than avg
Panel avg: 160d · This submission: 22d
Pathway characteristics
Standards-based clearance path.

Device Classification

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.

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