Cleared Traditional

MAXIMA, TRUSTEX, RIA AND PREMIUM EL LES CONDOMS (K981955) - FDA 510(k) Clearance

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

K981955 · Ls Rubber Sdn Bhd · Obstetrics & Gynecology device
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Mar 1999
Decision
284d
Days
Class 2
Risk

K981955 is an FDA 510(k) clearance for the MAXIMA, TRUSTEX, RIA AND PREMIUM EL LES CONDOMS. Classified as Condom With Nonoxynol-9 (product code LTZ), Class II - Special Controls.

Submitted by Ls Rubber Sdn Bhd (Alpharetta, US). The FDA issued a Cleared decision on March 15, 1999 after a review of 284 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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.

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Submission Details

510(k) Number K981955 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1998
Decision Date March 15, 1999
Days to Decision 284 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
124d slower than avg
Panel avg: 160d · This submission: 284d
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.