Cleared Abbreviated

SHEER THIN AROMAS BLUE LATEX CONDOM (K004016) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K004016 · 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

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.

View all Eagle Twe, Inc. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 160d · This submission: 90d
Pathway characteristics
Standards-based clearance path.

Device Classification

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.

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All 400
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