Cleared Traditional

K031301 - ESTEEM STERILE POLYISOPRENE SURGICAL GL...

K031301 is the FDA 510(k) clearance for ESTEEM STERILE POLYISOPRENE SURGICAL GL... by Cardinalhealth. It is a Class 1 General Hospital device (product code KGO) cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K031301 · Cardinalhealth · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
174d
Days
Class 1
Risk

K031301 is an FDA 510(k) clearance for the ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES WITH COATING. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Cardinalhealth (Mcgaw Park, US). The FDA issued a Cleared decision on October 15, 2003 after a review of 174 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K031301 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2003
Decision Date October 15, 2003
Days to Decision 174 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 129d · This submission: 174d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 165
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K031301.
ALOETOUCH POWDER FREE, POLYMER COATED POLYISOPRENE SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA, NATURAL COLOUR
K040503 · Wrp Asia Pacific Sdn. Bhd. · Mar 2004
PROFEEL POWDER FREE, PLOYMER COATED POLYISOPRENE SURGICAL GLOVES, STERILE
K032942 · Wrp Asia Pacific Sdn. Bhd. · Dec 2003
ALOETOUCH POWDER FREE NEOPRENE SURGICAL GLOVES, STERILE, TURQUOISE COLOUR AND COATED WITH ALOE VERA
K032647 · Wrp Asia Pacific Sdn. Bhd. · Nov 2003
ALOETOUCH POWDER FREE LATEX SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA AND WITH PROTEIN CONTENT LABELING CLAIM (50
K032464 · Wrp Asia Pacific Sdn. Bhd. · Aug 2003
POWDER FREE POLYMER COATED GREEN NEOPRENE SURGICAL GLOVES, STERILE
K024130 · Wrp Asia Pacific Sdn. Bhd. · Dec 2002
POWDER FREE GREEN NEOPRENE SURGICAL GLOVES, STERILE WITH ALOE VERA
K022444 · Wrp Asia Pacific Sdn. Bhd. · Sep 2002