Cleared Abbreviated

K033541 - LONG LOVE CONDOM

K033541 is an FDA 510(k) clearance for LONG LOVE CONDOM, manufactured by Unidus Corp.. 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.

K033541 · Unidus Corp. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2003
Decision
43d
Days
Class 2
Risk

K033541 is an FDA 510(k) clearance for the LONG LOVE CONDOM. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Unidus Corp. (Durham, US). The FDA issued a Cleared decision on December 23, 2003 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.

FDA 510(k) Submission Details - K033541

510(k) Number K033541 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 2003
Decision Date December 23, 2003
Days to Decision 43 days
Submission Type Abbreviated
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
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 401
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K033541.
PERSONAL WARMING LUBRICANT
K040085 · Qualis, Inc. · Apr 2004
DUREX FLAVORED LATEX CONDOM
K032227 · Ssl Americas, Inc. · Mar 2004
DUREX PLAY LUBRICANT
K032124 · Ssl Americas, Inc. · Jan 2004
LIFESTYLES LIQUID PERSONAL LUBRICANT
K033076 · Ansell Healthcare, Inc. · Dec 2003
THAI NIPPON EXTRA STRENGTH MALE LATEX CONDOM
K032909 · Thai Nippon Rubber Industry Co., Ltd. · Dec 2003
KWIKEZE MALE CONDOM APPLICATOR
K031007 · Condax, LLC · Nov 2003
K033541 · LONG LOVE CONDOM
Download PDF FDA Summary Unidus Corp.