Cleared Traditional

K891649 - PATIENT EXAMINATION GLOVES (LATEX)
(FDA 510(k) Clearance)

K891649 · Lic-Orthion · General Hospital

Apr 1989

Decision

18d

Days

Class 1

Risk

K891649 is an FDA 510(k) clearance for the PATIENT EXAMINATION GLOVES (LATEX), a Latex Patient Examination Glove (Class I — General Controls, product code LYY), submitted by Lic-Orthion (Lynchburg, US). The FDA issued a Cleared decision on April 4, 1989, 18 days after receiving the submission on March 17, 1989. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number	K891649 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 17, 1989
Decision Date	April 04, 1989
Days to Decision	18 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.