Cleared Abbreviated

K002571 - MULITPLE MALE LATX CONDOM

K002571 is an FDA 510(k) clearance for MULITPLE MALE LATX CONDOM, 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 90-day FDA review.

K002571 · Pleasure Latex Products Sdn. Bhd. · Obstetrics & Gynecology device
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Nov 2000
Decision
90d
Days
Class 2
Risk

K002571 is an FDA 510(k) clearance for the MULITPLE MALE LATX CONDOM. 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 November 16, 2000 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 884.5300 - 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 - K002571

510(k) Number K002571 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 2000
Decision Date November 16, 2000
Days to Decision 90 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
71d faster than avg
Panel avg: 161d · This submission: 90d
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 K002571.
SHEER THIN AROMAS BLUE LATEX CONDOM
K004016 · Eagle Twe, Inc. · Mar 2001
SHEER THIN AROMAS GREEN LATEX CONDOM
K004036 · Eagle Twe, Inc. · Mar 2001
NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOM
K002393 · Innolatex Sdn. Bhd · Dec 2000
NATURAL ORDINARY RIBBED,DOTTED,AND CONTOURED (MALE RUBBER LATEX CONDOM, LUBRICATED W/SILICONE OIL
K002060 · Dongkuk Techco Rubber Industries · Sep 2000
REMED MALE TUTTI FRUTTI CONDOM (BANANA), PREVENTOR, LUCKY BOY, SUMMIT
K993389 · Remed Pharma · Aug 2000
REMED MALE TUTTI FRUTTI CONDOM (STRAWBERRY) PREVENTOR, LUCKY BOY, SUMMIT
K993403 · Remed Pharma · Aug 2000
K002571 · MULITPLE MALE LATX CONDOM
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