Cleared Traditional

ULTRA THIN MALE LATEX CONDOM WITH SILICONE LUBRICANT (K012665) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K012665 · Innolatex Sdn. Bhd · Obstetrics & Gynecology device
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Nov 2001
Decision
88d
Days
Class 2
Risk

K012665 is an FDA 510(k) clearance for the ULTRA THIN MALE LATEX CONDOM WITH SILICONE LUBRICANT. 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 November 9, 2001 after a review of 88 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Innolatex Sdn. Bhd devices

Submission Details

510(k) Number K012665 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2001
Decision Date November 09, 2001
Days to Decision 88 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 160d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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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