Cleared Abbreviated

K051273 - DIVAS DUAL PLEASURE MALE LATEX CONDOM

K051273 is an FDA 510(k) clearance for DIVAS DUAL PLEASURE MALE LATEX CONDOM, manufactured by Eagle Twe, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Abbreviated 510(k) pathway after a 94-day FDA review.

K051273 · Eagle Twe, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2005
Decision
94d
Days
Class 2
Risk

K051273 is an FDA 510(k) clearance for the DIVAS DUAL PLEASURE MALE LATEX CONDOM. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Eagle Twe, Inc. (Tucker, US). The FDA issued a Cleared decision on August 19, 2005 after a review of 94 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 - K051273

510(k) Number K051273 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2005
Decision Date August 19, 2005
Days to Decision 94 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
67d faster than avg
Panel avg: 161d · This submission: 94d
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 K051273.
MALE NATURAL RUBBER LATEX CONDOM
K053367 · Innolatex Sdn. Bhd · Feb 2006
VIELLE LUBRICANT
K051288 · Cst Medical Limited · Feb 2006
DUREX MALE COLORED LATEX CONDOMS WITH SCENTED LUBRICANTS
K052959 · Ssl Americas · Jan 2006
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
TULIP CONDOM
K050360 · Shanghai Latex Factory · Mar 2005
K051273 · DIVAS DUAL PLEASURE MALE LATEX CONDOM
Download PDF FDA Summary Eagle Twe, Inc.