Cleared Traditional

K974326 - LATEX CONDOMS (NATURAL COLOUR)

K974326 is an FDA 510(k) clearance for LATEX CONDOMS (NATURAL COLOUR), manufactured by Reddy Medtech Health Products , Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code LTZ cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K974326 · Reddy Medtech Health Products , Ltd. · Obstetrics & Gynecology device
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Feb 1998
Decision
83d
Days
Class 2
Risk

K974326 is an FDA 510(k) clearance for the LATEX CONDOMS (NATURAL COLOUR). Classified as Condom With Nonoxynol-9 (product code LTZ), Class II - Special Controls.

Submitted by Reddy Medtech Health Products , Ltd. (Plainsboro, US). The FDA issued a Cleared decision on February 9, 1998 after a review of 83 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 Reddy Medtech Health Products , Ltd. devices

FDA 510(k) Submission Details - K974326

510(k) Number K974326 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1997
Decision Date February 09, 1998
Days to Decision 83 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 161d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LTZ Device Classification - Class 2, Special Controls

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.

Regulatory Peers - LTZ Condom With Nonoxynol-9

All 21
Devices cleared under the same product code (LTZ) and FDA review panel - the closest regulatory comparables to K974326.
MAXIMA, TRUSTEX, RIA AND PREMIUM EL LES CONDOMS
K981955 · Ls Rubber Sdn Bhd · Mar 1999
ROYALE OF LATEX CONDOMS - SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS
K981621 · Suretex Prophylactics (India) , Ltd. · Jun 1998
LATEX CONDOMS COLOUR WITH SPERMICIDAL LUBRICANT
K974324 · Reddy Medtech Health Products , Ltd. · Feb 1998
ROYALE BRAND LATEX CONDOMS-SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS
K972836 · G. Premjee (Usa), Inc. · Oct 1997
INNERWEAR, GENTLEMEN'S CHOICE W/NONOXYNOL-9
K972429 · Custom Services Intl., Inc. · Sep 1997
EXTRAWEAR, GENTLEMEN'S CHOICE W/NONOXYNOL-9
K972430 · Custom Services Intl., Inc. · Sep 1997