Cleared Traditional

ROYALE BRAND LATEX CONDOMS (SILICONE)-COLORED/ASSORTED COLORS (K971132) - FDA 510(k) Clearance

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

K971132 · G. Premjee (Usa), Inc. · Obstetrics & Gynecology device
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Sep 1997
Decision
160d
Days
Class 2
Risk

K971132 is an FDA 510(k) clearance for the ROYALE BRAND LATEX CONDOMS (SILICONE)-COLORED/ASSORTED COLORS. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by G. Premjee (Usa), Inc. (Great Neck, US). The FDA issued a Cleared decision on September 3, 1997 after a review of 160 days - an extended review 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: 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.

View all G. Premjee (Usa), Inc. devices

Submission Details

510(k) Number K971132 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1997
Decision Date September 03, 1997
Days to Decision 160 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
At panel average
Panel avg: 160d · This submission: 160d
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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