Cleared Special

K020659 - DUREX LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT

K020659 is an FDA 510(k) clearance for DUREX LATEX CONDOM WITH MALE GENITAL DE..., manufactured by Ssl Americas, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Special 510(k) pathway after a 28-day FDA review.

K020659 · Ssl Americas, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2002
Decision
28d
Days
Class 2
Risk

K020659 is an FDA 510(k) clearance for the DUREX LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Ssl Americas, Inc. (Norcross, US). The FDA issued a Cleared decision on March 29, 2002 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5300 - the FDA obstetrics and gynecology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K020659

510(k) Number K020659 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2002
Decision Date March 29, 2002
Days to Decision 28 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
133d faster than avg
Panel avg: 161d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

HIS Device Classification - Class 2, Special Controls

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.

Regulatory Peers - HIS Condom

All 364
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K020659.
MALE LATEX CONDOM WITH DOTTED/RIBBED SURFACE AND COUNOUR-WALLED SHAPE (3 IN 1 ULTIMATE MALE LATEX CONDOM
K021875 · Pleasure Latex Products Sdn. Bhd. · Sep 2002
NATURAL AND COLORED LATEX CONDOM WITH FLAVORS
K020633 · Ls Rubber Sdn Bhd · May 2002
MALE LATEX CONDOM WITH RIBBED SURFACE
K020272 · Pleasure Latex Products Sdn. Bhd. · Apr 2002
JOE LUBE CONDOM
K011363 · Marketing Sales Concepts, Inc. (Msci) · Mar 2002
JOE LUB HELMET CONDOM
K011378 · Marketing Sales Concepts, Inc. (Msci) · Mar 2002
INVIGRA
K020223 · Indus Medicare , Ltd. · Mar 2002
K020659 · DUREX LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT
Download PDF FDA Summary Ssl Americas, Inc.