Cleared Abbreviated

K032909 - THAI NIPPON EXTRA STRENGTH MALE LATEX CONDOM

K032909 is an FDA 510(k) clearance for THAI NIPPON EXTRA STRENGTH MALE LATEX C..., manufactured by Thai Nippon Rubber Industry Co., Ltd.. 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.

K032909 · Thai Nippon Rubber Industry Co., Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2003
Decision
90d
Days
Class 2
Risk

K032909 is an FDA 510(k) clearance for the THAI NIPPON EXTRA STRENGTH MALE LATEX CONDOM. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Thai Nippon Rubber Industry Co., Ltd. (Durham, US). The FDA issued a Cleared decision on December 16, 2003 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 - K032909

510(k) Number K032909 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2003
Decision Date December 16, 2003
Days to Decision 90 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
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 275
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K032909.
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K033076 · Ansell Healthcare, Inc. · Dec 2003
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K031007 · Condax, LLC · Nov 2003
MERCATOR HEALTHCARE MALE LATEX CONDOM
K031369 · Mercator Healthcare , Ltd. · Oct 2003
MULTIPLE, MALE LATEX CONDOM [52MM OR 56MM NOMINAL WIDTH WITH SMOOTH OR DOTTED OR RIBBED OR 3 IN 1 (DOTTED/RIBBED/CONTOUR
K023333 · Pleasure Latex Products Sdn. Bhd. · Jun 2003