GLOVCO BRAND POWDER-FREE NITRILE EXAMINATION GLOVES (PURPLE)


Device Classification Name

polymer patient examination glove

510(k) Number K021730
Device Name GLOVCO BRAND POWDER-FREE NITRILE EXAMINATION GLOVES (PURPLE)
Original Applicant
GLOVCO (M) SDN. BHD.
lot 760,(block a),jalan haji
sirat,off jalan meru
klang, selangor d.e., 

MY

42100

Original Contact tan peng hock
Regulation Number 880.6250
Classification Product Code
LZA  
Date Received 05/24/2002
Decision Date 07/05/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No