Cleared Traditional

K004051 - SHEER THIN AROMAS YELLOW LATEX CONDOM

K004051 is an FDA 510(k) clearance for SHEER THIN AROMAS YELLOW LATEX CONDOM, manufactured by Eagle Twe, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K004051 · Eagle Twe, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2001
Decision
90d
Days
Class 2
Risk

K004051 is an FDA 510(k) clearance for the SHEER THIN AROMAS YELLOW 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 March 29, 2001 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Eagle Twe, Inc. devices

FDA 510(k) Submission Details - K004051

510(k) Number K004051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2000
Decision Date March 29, 2001
Days to Decision 90 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 160d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 158
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K004051.
TROJAN THINTENSITY BRAND MALE LATEX CONDOM
K071272 · Church & Dwight Co., Inc. · Sep 2007
ASTROGLIDE BRAND WARMING LIQUID PERSONAL LUBRICANT
K041432 · Biofilm, Inc. · Nov 2004
TROJAN MINT TINGLE BRAND LATEX CONDOMS
K023405 · Armkel, LLC · Dec 2002
REMED MALE TUTTI FRUTTI CONDOM (BANANA), PREVENTOR, LUCKY BOY, SUMMIT
K993389 · Remed Pharma · Aug 2000
REMED MALE TUTTI FRUTTI CONDOM (STRAWBERRY) PREVENTOR, LUCKY BOY, SUMMIT
K993403 · Remed Pharma · Aug 2000
REMED MALE TUTTI FRUTTI CONDOM (COCONUT) PREVENTOR, LUCKY BOY, SUMMIT
K993409 · Remed Pharma · Aug 2000