Cleared Abbreviated

K041837 - INNOLATEX MALE LATEX CONDOMS COLORED AND SCENTED

K041837 is an FDA 510(k) clearance for INNOLATEX MALE LATEX CONDOMS COLORED AN..., manufactured by Innolatex Sdn. Bhd. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Abbreviated 510(k) pathway after a 79-day FDA review.

K041837 · Innolatex Sdn. Bhd · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2004
Decision
79d
Days
Class 2
Risk

K041837 is an FDA 510(k) clearance for the INNOLATEX MALE LATEX CONDOMS COLORED AND SCENTED. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Innolatex Sdn. Bhd (Durham, US). The FDA issued a Cleared decision on September 24, 2004 after a review of 79 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.

FDA 510(k) Submission Details - K041837

510(k) Number K041837 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2004
Decision Date September 24, 2004
Days to Decision 79 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
82d faster than avg
Panel avg: 161d · This submission: 79d
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 396
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K041837.
SAN-MAR LABS LUBRICATING JELLY
K041667 · San-Mar Laboratories, Inc. · Jan 2005
POWERSTICK MALE LATEX CONDOMS
K041717 · A.P.Deauville, LLC · Jan 2005
ASTROGLIDE BRAND WARMING LIQUID PERSONAL LUBRICANT
K041432 · Biofilm, Inc. · Nov 2004
DUREX STUDDED/RIBBED LUBRICATED LATEX CONDOM
K040185 · Ssl Americas · Apr 2004
PERSONAL WARMING LUBRICANT
K040085 · Qualis, Inc. · Apr 2004
DUREX FLAVORED LATEX CONDOM
K032227 · Ssl Americas, Inc. · Mar 2004
K041837 · INNOLATEX MALE LATEX CONDOMS COLORED AND SCENTED
Download PDF FDA Summary Innolatex Sdn. Bhd