STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE


Device Classification Name

polymer patient examination glove

510(k) Number K081466
Device Name STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
Applicant
SMART GLOVE CORP. SDN BHD
lot 6487 batu 5 3/4
jalan kapar
klang selangor, 

MY

42100

Applicant Contact foo khon pu
Correspondent
SMART GLOVE CORP. SDN BHD
lot 6487 batu 5 3/4
jalan kapar
klang selangor, 

MY

42100

Correspodent Contact foo khon pu
Regulation Number 880.6250
Classification Product Code
LZA  
Date Received 05/27/2008
Decision Date 07/30/2008
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