Cleared Abbreviated

K020272 - MALE LATEX CONDOM WITH RIBBED SURFACE

K020272 is an FDA 510(k) clearance for MALE LATEX CONDOM WITH RIBBED SURFACE, manufactured by Pleasure Latex Products Sdn. Bhd.. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Abbreviated 510(k) pathway after a 88-day FDA review.

K020272 · Pleasure Latex Products Sdn. Bhd. · Obstetrics & Gynecology device
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Apr 2002
Decision
88d
Days
Class 2
Risk

K020272 is an FDA 510(k) clearance for the MALE LATEX CONDOM WITH RIBBED SURFACE. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Pleasure Latex Products Sdn. Bhd. (Jeram, Selangor Darul Ehsan, MY). The FDA issued a Cleared decision on April 26, 2002 after a review of 88 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. 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.

FDA 510(k) Submission Details - K020272

510(k) Number K020272 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2002
Decision Date April 26, 2002
Days to Decision 88 days
Submission Type Abbreviated
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
73d faster than avg
Panel avg: 161d · This submission: 88d
Pathway characteristics
Standards-based clearance path.

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 318
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K020272.
CONDOMI NATURE, CONDOMI STIMULATION, CONDOMI VANILLA GOLD, CONDOMI SUPERSAFE, CONDOMI XXL, CONDOMI STRONG,
K021186 · Condomi Erfert Prodoktionsgesellschaft Mbh · Oct 2002
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
DUREX LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT
K020659 · Ssl Americas, Inc. · Mar 2002
JOE LUBE CONDOM
K011363 · Marketing Sales Concepts, Inc. (Msci) · Mar 2002
JOE LUB HELMET CONDOM
K011378 · Marketing Sales Concepts, Inc. (Msci) · Mar 2002
K020272 · MALE LATEX CONDOM WITH RIBBED SURFACE
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