Cleared Traditional

LATEX EXAMINATION GLOVES NON-STERILE

K890356 · Quest Intl., Inc. · General Hospital

Apr 1989

Decision

72d

Days

Class 1

Risk

About This 510(k) Submission

K890356 is an FDA 510(k) clearance for the LATEX EXAMINATION GLOVES NON-STERILE, a Latex Patient Examination Glove (Class I — General Controls, product code LYY), submitted by Quest Intl., Inc. (Fort Smith, US). The FDA issued a Cleared decision on April 6, 1989, 72 days after receiving the submission on January 24, 1989. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number	K890356 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 24, 1989
Decision Date	April 06, 1989
Days to Decision	72 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.