Cleared Traditional

STERILE PATIENT EXAMINATION GLOVES

K903756 · Tillotson Rubber Co., Inc. · General Hospital

Sep 1990

Decision

23d

Days

Class 1

Risk

About This 510(k) Submission

K903756 is an FDA 510(k) clearance for the STERILE PATIENT EXAMINATION GLOVES, a Latex Patient Examination Glove (Class I — General Controls, product code LYY), submitted by Tillotson Rubber Co., Inc. (Newton Centre, US). The FDA issued a Cleared decision on September 5, 1990, 23 days after receiving the submission on August 13, 1990. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number	K903756 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 13, 1990
Decision Date	September 05, 1990
Days to Decision	23 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	—

Device Classification

Product Code	LYY — Latex Patient Examination Glove
Device Class	Class I — General Controls
CFR Regulation	21 CFR 880.6250
Definition	A Latex Patient Examination Glove Is A Disposable Device Made Of Natural Rubber Latex That May Or May Not Bear A Trace Amount Of Residual Powder, And Is Intended To Be Worn On The Hand For Medical Purposes To Provide A Barrier Against Potentially Infectious Materials And Other Contaminants.