Cleared Abbreviated

K003375 - CONTROL MALE CONDOMS OF NATURAL RUBBER LATEX

K003375 is an FDA 510(k) clearance for CONTROL MALE CONDOMS OF NATURAL RUBBER ..., manufactured by Tecnilatex S.A.. The device is a Class 2 Obstetrics & Gynecology device with product code LTZ cleared through the Abbreviated 510(k) pathway after a 90-day FDA review.

K003375 · Tecnilatex S.A. · Obstetrics & Gynecology device
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Jan 2001
Decision
90d
Days
Class 2
Risk

K003375 is an FDA 510(k) clearance for the CONTROL MALE CONDOMS OF NATURAL RUBBER LATEX. Classified as Condom With Nonoxynol-9 (product code LTZ), Class II - Special Controls.

Submitted by Tecnilatex S.A. (Madrid, ES). The FDA issued a Cleared decision on January 28, 2001 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5310 - the FDA obstetrics and gynecology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Tecnilatex S.A. devices

FDA 510(k) Submission Details - K003375

510(k) Number K003375 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2000
Decision Date January 28, 2001
Days to Decision 90 days
Submission Type Abbreviated
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 160d · This submission: 90d
Pathway characteristics
Standards-based clearance path.

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 16
Devices cleared under the same product code (LTZ) and FDA review panel - the closest regulatory comparables to K003375.
INVIGRA PLUS (WITH SPERMICIDAL LUBRICANT)
K992438 · Indus Medicare , Ltd. · Aug 1999
HARDCOVER CONDOMS MALE LATEX CONDOMS, (WITH SPERMICIDE)
K991047 · Hardcover Products, Inc. · Jun 1999
MULTIPLE-BRAND MALE LATEX CONDOM (LUBRICATED WITH NONOXYNOL-9)
K990669 · Dongkuk Techco Rubber Industries Sdn. Bhd. · May 1999
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