Cleared Traditional

K833093 - VANISH II
(FDA 510(k) Clearance)

K833093 · Warner-Lambert Co. · General Hospital

Dec 1983

Decision

91d

Days

Class 1

Risk

K833093 is an FDA 510(k) clearance for the VANISH II. This device is classified as a Surgeon's Gloves (Class I — General Controls, product code KGO).

Submitted by Warner-Lambert Co. (Mchenry, US). The FDA issued a Cleared decision on December 12, 1983, 91 days after receiving the submission on September 12, 1983.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4460. 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..

Submission Details

510(k) Number	K833093 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 12, 1983
Decision Date	December 12, 1983
Days to Decision	91 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	—

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.