Cleared Abbreviated

K070830 - MALE NATURAL RUBBER LATEX CONDOM (WITH COLORING AND FLAVORING)

K070830 is an FDA 510(k) clearance for MALE NATURAL RUBBER LATEX CONDOM (WITH ..., 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 43-day FDA review.

K070830 · Karex Industries Sdn. Bhd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2007
Decision
43d
Days
Class 2
Risk

K070830 is an FDA 510(k) clearance for the MALE NATURAL RUBBER LATEX CONDOM (WITH COLORING AND FLAVORING). 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 May 8, 2007 after a review of 43 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.

View all Karex Industries Sdn. Bhd. devices

FDA 510(k) Submission Details - K070830

510(k) Number K070830 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2007
Decision Date May 08, 2007
Days to Decision 43 days
Submission Type Abbreviated
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 161d · This submission: 43d
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
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K070830.
TROJAN-ENZ BRAND
K071313 · Church & Dwight Co., Inc. · Oct 2007
MULTIPLE BRAND MALE LATEX CONDOM
K070937 · Nulatex Sdn. Bhd. · Sep 2007
TROJAN THINTENSITY BRAND MALE LATEX CONDOM
K071272 · Church & Dwight Co., Inc. · Sep 2007
BANANA RIBBED
K063401 · Medtech Products , Ltd. · Mar 2007
NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOMS
K062730 · Biogreen Medical Sdn. Bhd. · Oct 2006
ZEUS MALE CONDOM APPLICATOR
K052206 · Condax, LLC · Sep 2006