Cleared Abbreviated

K052959 - DUREX MALE COLORED LATEX CONDOMS WITH SCENTED LUBRICANTS

K052959 is an FDA 510(k) clearance for DUREX MALE COLORED LATEX CONDOMS WITH S..., manufactured by Ssl Americas. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Abbreviated 510(k) pathway after a 98-day FDA review.

K052959 · Ssl Americas · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2006
Decision
98d
Days
Class 2
Risk

K052959 is an FDA 510(k) clearance for the DUREX MALE COLORED LATEX CONDOMS WITH SCENTED LUBRICANTS. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Ssl Americas (Norcross, US). The FDA issued a Cleared decision on January 27, 2006 after a review of 98 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 - K052959

510(k) Number K052959 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 2005
Decision Date January 27, 2006
Days to Decision 98 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
63d faster than avg
Panel avg: 161d · This submission: 98d
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 365
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K052959.
DICK'S FORMALWEAR MALE LATEX CONDOM
K050913 · Dick'S Formalwear, Inc. · Apr 2006
MALE NATURAL RUBBER LATEX CONDOM
K053367 · Innolatex Sdn. Bhd · Feb 2006
VIELLE LUBRICANT
K051288 · Cst Medical Limited · Feb 2006
DIVAS DUAL PLEASURE MALE LATEX CONDOM
K051273 · Eagle Twe, Inc. · Aug 2005
MALE NATURAL RUBBER LATEX CONDOM
K050244 · Nrs Global Partners · Apr 2005
DUREX SPEARMINT SCENTED LUBRICATED LATEX CONDOM (DUREX 'TINGLING PLEASURE' CONDOM
K042470 · Ssl Americas, Inc. · Apr 2005
K052959 · DUREX MALE COLORED LATEX CONDOMS WITH SCENTED LUBRICANTS
Download PDF FDA Summary Ssl Americas