NITRILE EXAMINATION GLOVES, PRE-POWDERED


Device Classification Name

polymer patient examination glove

510(k) Number K023979
Device Name NITRILE EXAMINATION GLOVES, PRE-POWDERED
Original Applicant
STARMATRIX SDN BHD
10, jalan ss 1/26
petaling jaya, selangor, 

MY

47300

Original Contact ngan goon seng
Regulation Number 880.6250
Classification Product Code
LZA  
Date Received 12/02/2002
Decision Date 01/24/2003
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