NITRILE POWDER FREE EXAMINATION GLOVES


Device Classification Name

polymer patient examination glove

510(k) Number K110758
Device Name NITRILE POWDER FREE EXAMINATION GLOVES
Applicant
HARTALEGA SDN BHD
no. 7, kawasan perusahaan
suria
bestari jaya, selangor, 

MY

45600

Applicant Contact nurul aisyah kong bt abdullah
Correspondent
HARTALEGA SDN BHD
no. 7, kawasan perusahaan
suria
bestari jaya, selangor, 

MY

45600

Correspodent Contact nurul aisyah kong bt abdullah
Regulation Number 880.6250
Classification Product Code
LZA  
Date Received 03/18/2011
Decision Date 08/12/2011
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