Cleared Traditional

TROJAN POLYURETHANE CONDOM (MODIFICATION) (K955672) - FDA 510(k) Clearance

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

K955672 · Carter Products · Obstetrics & Gynecology device
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Aug 1996
Decision
302d
Days
Class 2
Risk

K955672 is an FDA 510(k) clearance for the TROJAN POLYURETHANE CONDOM (MODIFICATION). Classified as Condom, Synthetic (product code MOL), Class II - Special Controls.

Submitted by Carter Products (Cranbury, US). The FDA issued a Cleared decision on August 29, 1996 after a review of 302 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Carter Products devices

Submission Details

510(k) Number K955672 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1995
Decision Date August 29, 1996
Days to Decision 302 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
142d slower than avg
Panel avg: 160d · This submission: 302d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MOL Condom, Synthetic
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 - MOL Condom, Synthetic

All 21
Devices cleared under the same product code (MOL) and FDA review panel - the closest regulatory comparables to K955672.
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Polyisoprene Extra Large Condom
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K231908 · Suretex Limited · Oct 2023