Cleared Traditional

Hi Coat Powder Free Latex Patient Examination Gloves

K972539 · P.T. Latexindo Tobaperkasa · General Hospital

Nov 1997

Decision

133d

Days

Class 1

Risk

About This 510(k) Submission

K972539 is an FDA 510(k) clearance for the Hi Coat Powder Free Latex Patient Examination Gloves, a Latex Patient Examination Glove (Class I — General Controls, product code LYY), submitted by P.T. Latexindo Tobaperkasa (Medan, ID). The FDA issued a Cleared decision on November 18, 1997, 133 days after receiving the submission on July 8, 1997. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number	K972539 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 08, 1997
Decision Date	November 18, 1997
Days to Decision	133 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement

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.