SINGLE USE, DISPOSABLE, BLUE COLOR, POWDER FREE LATEX PATIENT EXAMINATION GLOVE


Device Classification Name

latex patient examination glove

510(k) Number K072802
Device Name SINGLE USE, DISPOSABLE, BLUE COLOR, POWDER FREE LATEX PATIENT EXAMINATION GLOVE
Applicant
ULTRAWIN SDN BHD
12-a, tam,an ros jalan sultan
abdullah
teluk intan, 

MY

36000

Applicant Contact siew-hoe mah
Correspondent
ULTRAWIN SDN BHD
12-a, tam,an ros jalan sultan
abdullah
teluk intan, 

MY

36000

Correspodent Contact siew-hoe mah
Regulation Number 880.6250
Classification Product Code
LYY  
Date Received 10/01/2007
Decision Date 02/29/2008
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