Cleared Traditional

Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove

K201592 · Cardinal Health200, LLC · General Hospital
Sep 2021
Decision
471d
Days
Class 1
Risk

About This 510(k) Submission

K201592 is an FDA 510(k) clearance for the Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove, a Surgeon's Gloves (Class I — General Controls, product code KGO), submitted by Cardinal Health200, LLC (Waukegan, US). The FDA issued a Cleared decision on September 26, 2021, 471 days after receiving the submission on June 12, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4460.

Submission Details

510(k) Number K201592 FDA.gov
FDA Decision Cleared SESE
Date Received June 12, 2020
Decision Date September 26, 2021
Days to Decision 471 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

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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