Cleared Special

CARDINAL HEALTH PROTEGRITY BLUE WITH NEU-THERA SURGICAL GLOVES

K053272 · Cardinalhealth · General Hospital
Jan 2006
Decision
43d
Days
Class 1
Risk

About This 510(k) Submission

K053272 is an FDA 510(k) clearance for the CARDINAL HEALTH PROTEGRITY BLUE WITH NEU-THERA SURGICAL GLOVES, a Surgeon's Gloves (Class I — General Controls, product code KGO), submitted by Cardinalhealth (Waukegan, US). The FDA issued a Cleared decision on January 5, 2006, 43 days after receiving the submission on November 23, 2005. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4460.

Submission Details

510(k) Number K053272 FDA.gov
FDA Decision Cleared SESE
Date Received November 23, 2005
Decision Date January 05, 2006
Days to Decision 43 days
Submission Type Special
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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