Cleared Abbreviated

K001377 - SPERMICIDAL LUBRICATED MALE LATEX CONDOM

K001377 is an FDA 510(k) clearance for SPERMICIDAL LUBRICATED MALE LATEX CONDOM, manufactured by Pleasure Latex Products Sdn. Bhd.. The device is a Class 2 Obstetrics & Gynecology device with product code LTZ cleared through the Abbreviated 510(k) pathway after a 38-day FDA review.

K001377 · Pleasure Latex Products Sdn. Bhd. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Jun 2000
Decision
38d
Days
Class 2
Risk

K001377 is an FDA 510(k) clearance for the SPERMICIDAL LUBRICATED MALE LATEX CONDOM. Classified as Condom With Nonoxynol-9 (product code LTZ), Class II - Special Controls.

Submitted by Pleasure Latex Products Sdn. Bhd. (Jeram, Selangor Darul Ehsan, MY). The FDA issued a Cleared decision on June 8, 2000 after a review of 38 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 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 Pleasure Latex Products Sdn. Bhd. devices

FDA 510(k) Submission Details - K001377

510(k) Number K001377 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2000
Decision Date June 08, 2000
Days to Decision 38 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
122d faster than avg
Panel avg: 160d · This submission: 38d
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 9
Devices cleared under the same product code (LTZ) and FDA review panel - the closest regulatory comparables to K001377.
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
LATEX CONDOMS (NATURAL COLOUR)
K974326 · 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