Cleared Traditional

K894073 - INAMED PRO-TEC SILICONE SURGICAL GLOVES
(FDA 510(k) Clearance)

K894073 · Inamed Development Co. · General Hospital

Sep 1989

Decision

102d

Days

Class 1

Risk

K894073 is an FDA 510(k) clearance for the INAMED PRO-TEC SILICONE SURGICAL GLOVES, a Surgeon's Gloves (Class I — General Controls, product code KGO), submitted by Inamed Development Co. (Carpinteria, US). The FDA issued a Cleared decision on September 18, 1989, 102 days after receiving the submission on June 8, 1989. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4460.

Submission Details

510(k) Number	K894073 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 08, 1989
Decision Date	September 18, 1989
Days to Decision	102 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.