Cleared Traditional

POWDER FREE, NON-STERILE EXAMINATION GLOVES

K903607 · Tillotson Rubber Co., Inc. · General Hospital

Aug 1990

Decision

10d

Days

Class 1

Risk

About This 510(k) Submission

K903607 is an FDA 510(k) clearance for the POWDER FREE, NON-STERILE 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 August 17, 1990, 10 days after receiving the submission on August 7, 1990. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number	K903607 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 07, 1990
Decision Date	August 17, 1990
Days to Decision	10 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.