Cleared Abbreviated

K004016 - SHEER THIN AROMAS BLUE LATEX CONDOM

K004016 is an FDA 510(k) clearance for SHEER THIN AROMAS BLUE 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 90-day FDA review.

K004016 · Eagle Twe, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2001
Decision
90d
Days
Class 2
Risk

K004016 is an FDA 510(k) clearance for the SHEER THIN AROMAS BLUE 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 27, 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 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 - K004016

510(k) Number K004016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2000
Decision Date March 27, 2001
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 396
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K004016.
LIFESTYLES, CONTEMPO OR PRIVATE LABEL, MALE LATEX CONDOM WITH GLYCERINE LUBRICANT
K010371 · Suretex, Ltd. · Apr 2001
SHEER THIN AROMAS RED LATEX CONDOM
K010028 · Eagle Twe, Inc. · Mar 2001
SHEER THIN AROMAS YELLOW LATEX CONDOM
K004051 · Eagle Twe, Inc. · Mar 2001
SHEER THIN AROMAS GREEN LATEX CONDOM
K004036 · Eagle Twe, Inc. · Mar 2001
NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOM
K002393 · Innolatex Sdn. Bhd · Dec 2000
MULITPLE MALE LATX CONDOM
K002571 · Pleasure Latex Products Sdn. Bhd. · Nov 2000
K004016 · SHEER THIN AROMAS BLUE LATEX CONDOM
Download PDF FDA Summary Eagle Twe, Inc.