Cleared Traditional

K092304 - ESTEEM ORTHO POLYISOPRENE POWDER-FREE S...

K092304 is an FDA 510(k) clearance for ESTEEM ORTHO POLYISOPRENE POWDER-FREE S..., manufactured by Cardinal Health, Inc.. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K092304 · Cardinal Health, Inc. · General Hospital
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Sep 2009
Decision
48d
Days
Class 1
Risk

K092304 is an FDA 510(k) clearance for the ESTEEM ORTHO POLYISOPRENE POWDER-FREE SURGICAL GLOVES. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Cardinal Health, Inc. (Waukegan, US). The FDA issued a Cleared decision on September 15, 2009 after a review of 48 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4460 - the FDA general hospital 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cardinal Health, Inc. devices

FDA 510(k) Submission Details - K092304

510(k) Number K092304 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2009
Decision Date September 15, 2009
Days to Decision 48 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 129d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

KGO Device Classification - Class 1, General Controls

Product Code KGO Surgeon's Gloves
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4460
Definition A Surgeon's Glove Is A Disposable Device Made Of Natural Rubber Latex Or Synthetic Polymers That May Or May Not Bear Powder To Facilitate Donning, And It Is Intended To Be Worn On The Hands, Usually In Surgical Settings, To Provide A Barrier Against Potentially Infectious Materials And Other Contaminants.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KGO Surgeon's Gloves

All 189
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K092304.
BIOGEL ORTHOPOR BROWN SURGICAL GLOVE
K112089 · Molnlycke Health Care Us, LLC · Aug 2011
MEDLINE POWDER-FREE LATEX SURGICAL GLOVES, STERILE, W/ OR W/O ALOE VERA, WITH PROTEIN CONTENT LABELING CLAIM...
K111807 · Medline Industries, Inc. · Aug 2011
SENSICARE POWDER-FREE POLYMER COATED POLYSOPRENE SURGICAL GLOVES, STERILE
K102177 · Medline Industries, Inc. · Jun 2011
SKINSENSE POLYISOPRENE UNDERGLOVE
K081180 · Molnlycke Health Care Us, LLC · Aug 2008
BIOGEL ORTHOPAEDIC SURGICAL GLOVE WITH NON-PRYOGENIC STATEMENT
K071465 · Molnlycke Health Care Us, LLC · Sep 2007
BIOGEL SENSOR SURGEON'S GLOVE WITH NON-PYROGENIC STATEMENT
K071700 · Molnlycke Health Care Us, LLC · Sep 2007