POWDER FREE NITRILE (BLACK) EXAMINATION GLOVES


Device Classification Name

polymer patient examination glove

510(k) Number K110297
Device Name POWDER FREE NITRILE (BLACK) EXAMINATION GLOVES
Applicant
COMFORT RUBBER GLOVES INDUSTRIES SDN BHD
lot 821, jalan matang
taiping, perak, 

MY

34750

Applicant Contact tan keng beng
Correspondent
COMFORT RUBBER GLOVES INDUSTRIES SDN BHD
lot 821, jalan matang
taiping, perak, 

MY

34750

Correspodent Contact tan keng beng
Regulation Number 880.6250
Classification Product Code
LZA  
Date Received 02/01/2011
Decision Date 06/15/2011
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