Cleared Traditional

HPI ORTHO SURGEONS' GLOVE

K894828 · Tillotson Rubber Co., Inc. · General Hospital
May 1990
Decision
280d
Days
Class 1
Risk

About This 510(k) Submission

K894828 is an FDA 510(k) clearance for the HPI ORTHO SURGEONS' GLOVE, a Surgeon's Gloves (Class I — General Controls, product code KGO), submitted by Tillotson Rubber Co., Inc. (Newton Centre, US). The FDA issued a Cleared decision on May 7, 1990, 280 days after receiving the submission on July 31, 1989. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4460.

Submission Details

510(k) Number K894828 FDA.gov
FDA Decision Cleared SESE
Date Received July 31, 1989
Decision Date May 07, 1990
Days to Decision 280 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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