Cleared Abbreviated

K141059 - NATURAL RUBBER LATEX MALE CONDOMS

K141059 is an FDA 510(k) clearance for NATURAL RUBBER LATEX MALE CONDOMS, manufactured by Karex Industries Sdn. Bhd.. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Abbreviated 510(k) pathway after a 99-day FDA review.

K141059 · Karex Industries Sdn. Bhd. · Obstetrics & Gynecology device
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Aug 2014
Decision
99d
Days
Class 2
Risk

K141059 is an FDA 510(k) clearance for the NATURAL RUBBER LATEX MALE CONDOMS. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Karex Industries Sdn. Bhd. (Pontian Kecil, Jalan Johor, MY). The FDA issued a Cleared decision on August 1, 2014 after a review of 99 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.

View all Karex Industries Sdn. Bhd. devices

FDA 510(k) Submission Details - K141059

510(k) Number K141059 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2014
Decision Date August 01, 2014
Days to Decision 99 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
62d faster than avg
Panel avg: 161d · This submission: 99d
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 240
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