Cleared Traditional

GLOVES, SURGEONS, LATEX

K770704 · Tillotson Rubber Co., Inc. · General Hospital
Jun 1977
Decision
67d
Days
Class 1
Risk

About This 510(k) Submission

K770704 is an FDA 510(k) clearance for the GLOVES, SURGEONS, LATEX, a Surgeon's Gloves (Class I — General Controls, product code KGO), submitted by Tillotson Rubber Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on June 24, 1977, 67 days after receiving the submission on April 18, 1977. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4460.

Submission Details

510(k) Number K770704 FDA.gov
FDA Decision Cleared SESE
Date Received April 18, 1977
Decision Date June 24, 1977
Days to Decision 67 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.

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