Cleared Traditional

EXTRAWEAR, GENTLEMEN'S CHOICE W/NONOXYNOL-9 (K972430) - FDA 510(k) Clearance

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

K972430 · Custom Services Intl., Inc. · Obstetrics & Gynecology device
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Sep 1997
Decision
75d
Days
Class 2
Risk

K972430 is an FDA 510(k) clearance for the EXTRAWEAR, GENTLEMEN'S CHOICE W/NONOXYNOL-9. Classified as Condom With Nonoxynol-9 (product code LTZ), Class II - Special Controls.

Submitted by Custom Services Intl., Inc. (Las Vegas, US). The FDA issued a Cleared decision on September 10, 1997 after a review of 75 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5310 - 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 Custom Services Intl., Inc. devices

Submission Details

510(k) Number K972430 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 1997
Decision Date September 10, 1997
Days to Decision 75 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 160d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LTZ Condom With Nonoxynol-9
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5310
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.