Cleared Traditional

K042574 - ESTEEM BLUE POLYISOPRENE SURGICAL GLOVE...

K042574 is the FDA 510(k) clearance for ESTEEM BLUE POLYISOPRENE SURGICAL GLOVE... by Cardinalhealth. It is a Class 1 General Hospital device (product code KGO) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K042574 · Cardinalhealth · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2004
Decision
77d
Days
Class 1
Risk

K042574 is an FDA 510(k) clearance for the ESTEEM BLUE POLYISOPRENE SURGICAL GLOVES WITH COATING (CONTAINING CHITOSAN, P.... Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Cardinalhealth (Waukegan, US). The FDA issued a Cleared decision on December 8, 2004 after a review of 77 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 Cardinalhealth devices

Submission Details

510(k) Number K042574 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2004
Decision Date December 08, 2004
Days to Decision 77 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
52d faster than avg
Panel avg: 129d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

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 K042574.
ZIMMER CUT RESISTANT GLOVE LINER, XSMALL, SMALL, MEDIUM, LARGE, XLARGE
K063582 · Zimmer, Inc. · Apr 2007
POWDER FREE STERILE NITRILE SURGICAL GLOVES (BLUE)
K062950 · Hartalega Sdn Bhd · Dec 2006
POWDER FREE STERILE LATEX SURGICAL GLOVES
K052177 · Hartalega Sdn Bhd · Dec 2005
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