Cleared Traditional

POWDER FREE NITRILE EXAMINATION GLOVES - POLYMER COATED

K974443 · P.T. Latexindo Tobaperkasa · General Hospital

Jan 1998

Decision

41d

Days

Class 1

Risk

About This 510(k) Submission

K974443 is an FDA 510(k) clearance for the POWDER FREE NITRILE EXAMINATION GLOVES - POLYMER COATED, a Vinyl Patient Examination Glove (Class I — General Controls, product code LYZ), submitted by P.T. Latexindo Tobaperkasa (Medan, ID). The FDA issued a Cleared decision on January 5, 1998, 41 days after receiving the submission on November 25, 1997. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number	K974443 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 25, 1997
Decision Date	January 05, 1998
Days to Decision	41 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement

Device Classification

Product Code	LYZ — Vinyl Patient Examination Glove
Device Class	Class I — General Controls
CFR Regulation	21 CFR 880.6250
Definition	A Vinyl Patient Examination Glove Is A Disposable Device Made Of Poly(vinyl Chloride) 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.