GREEN POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES WITH PEPPERMINT FLAVOR


Device Classification Name

polymer patient examination glove

510(k) Number K024083
Device Name GREEN POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES WITH PEPPERMINT FLAVOR
Original Applicant
SUPERMAX GLOVE MANUFACTURING SDN BHD
lot 42, putra industrial park
bukit rahman putra
sungai buloh, selangor, 

MY

47000

Original Contact stanley thai
Regulation Number 880.6250
Classification Product Code
LZA  
Date Received 12/11/2002
Decision Date 01/10/2003
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