Cleared Traditional

LONDON ROYAL CONSUMER PRODUCTS LATEX CONDOMS (K953813) - FDA 510(k) Clearance

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

K953813 · London International U.S. Holdings, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1996
Decision
353d
Days
Class 2
Risk

K953813 is an FDA 510(k) clearance for the LONDON ROYAL CONSUMER PRODUCTS LATEX CONDOMS. Classified as Condom With Nonoxynol-9 (product code LTZ), Class II - Special Controls.

Submitted by London International U.S. Holdings, Inc. (Sarasota, US). The FDA issued a Cleared decision on July 22, 1996 after a review of 353 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5310 - 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: 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 London International U.S. Holdings, Inc. devices

Submission Details

510(k) Number K953813 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1995
Decision Date July 22, 1996
Days to Decision 353 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
193d slower than avg
Panel avg: 160d · This submission: 353d
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.