Cleared Abbreviated

NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOM (K002393) - FDA 510(k) Clearance

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

K002393 · Innolatex Sdn. Bhd · Obstetrics & Gynecology device
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Dec 2000
Decision
134d
Days
Class 2
Risk

K002393 is an FDA 510(k) clearance for the NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOM. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Innolatex Sdn. Bhd (Shah Alam,Selangor Darul Ehsan, MY). The FDA issued a Cleared decision on December 19, 2000 after a review of 134 days - within the typical 510(k) review window.

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

Submission Details

510(k) Number K002393 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2000
Decision Date December 19, 2000
Days to Decision 134 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
26d faster than avg
Panel avg: 160d · This submission: 134d
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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