Cleared Abbreviated

K994312 - MALE LATEX CONDOM 56MM

K994312 is an FDA 510(k) clearance for MALE LATEX CONDOM 56MM, 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.

K994312 · Pleasure Latex Products Sdn. Bhd. · Obstetrics & Gynecology device
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Mar 2000
Decision
90d
Days
Class 2
Risk

K994312 is an FDA 510(k) clearance for the MALE LATEX CONDOM 56MM. 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 March 21, 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 - K994312

510(k) Number K994312 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1999
Decision Date March 21, 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 K994312.
INVIGRA MALE LATEX CONDOM YELLOW COLORED AND BANANA FLAVORED
K000039 · Indus Medicare , Ltd. · Mar 2000
INVIGRA MALE LATEX CONDOM BLUE COLORED AND VANILLA FLAVORED
K000040 · Indus Medicare , Ltd. · Mar 2000
MALE LATEX CONDOM WITH VANILLA FLAVOR
K994311 · Pleasure Latex Products Sdn. Bhd. · Mar 2000
LOVE LOCKERS
K993733 · Medtech Products , Ltd. · Mar 2000
DOUBLE SPRINGERS
K993735 · Medtech Products , Ltd. · Mar 2000
MIGHTY MAN (DYNAMIC LINKERS)
K993737 · Medtech Products , Ltd. · Mar 2000
K994312 · MALE LATEX CONDOM 56MM
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