Cleared Abbreviated

K070937 - MULTIPLE BRAND MALE LATEX CONDOM

K070937 is an FDA 510(k) clearance for MULTIPLE BRAND MALE LATEX CONDOM, manufactured by Nulatex Sdn. Bhd.. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Abbreviated 510(k) pathway after a 170-day FDA review.

K070937 · Nulatex Sdn. Bhd. · Obstetrics & Gynecology device
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Sep 2007
Decision
170d
Days
Class 2
Risk

K070937 is an FDA 510(k) clearance for the MULTIPLE BRAND MALE LATEX CONDOM. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Nulatex Sdn. Bhd. (Kluang, Johor, MY). The FDA issued a Cleared decision on September 21, 2007 after a review of 170 days - an extended review 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 Nulatex Sdn. Bhd. devices

FDA 510(k) Submission Details - K070937

510(k) Number K070937 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2007
Decision Date September 21, 2007
Days to Decision 170 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
10d slower than avg
Panel avg: 160d · This submission: 170d
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 79
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K070937.
TROJAN MAGNUM CONDOM WITH FIRE & ICE LUBRICANT
K120287 · Church & Dwight Co., Inc. · May 2012
TROJAN THINTENSITY BRAND MALE LATEX CONDOM LUBRICATED WITH ULTRASMOOTH AND WARM SENSATIONS LUBRICANT
K073016 · Church & Dwight Co., Inc. · Nov 2007
TROJAN-ENZ BRAND
K071313 · Church & Dwight Co., Inc. · Oct 2007
TROJAN THINTENSITY BRAND MALE LATEX CONDOM
K071272 · Church & Dwight Co., Inc. · Sep 2007
TROJAN MINT TINGLE BRAND LATEX CONDOMS
K023405 · Armkel, LLC · Dec 2002
TROJAN EXTRA LARGE LATEX CONDOM
K001212 · Armkel, LLC · May 2000