Cleared Traditional

ESTEEM BLUE POLYISOPRENE SURGICAL GLOVES WITH COATING (CONTAINING CHITOSAN, PROVITAMIN B, GLUCONOLACTONE AND GLYCEROL)

K042574 · Cardinalhealth · General Hospital
Dec 2004
Decision
77d
Days
Class 1
Risk

About This 510(k) Submission

K042574 is an FDA 510(k) clearance for the ESTEEM BLUE POLYISOPRENE SURGICAL GLOVES WITH COATING (CONTAINING CHITOSAN, PROVITAMIN B, GLUCONOLACTONE AND GLYCEROL), a Surgeon's Gloves (Class I — General Controls, product code KGO), submitted by Cardinalhealth (Waukegan, US). The FDA issued a Cleared decision on December 8, 2004, 77 days after receiving the submission on September 22, 2004. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4460.

Submission Details

510(k) Number K042574 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code KGO — Surgeon's Gloves
Device Class Class I — 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.

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