POWDER-FREE LATEX EXAMINATION GLOVES – 18 MILS AT FINGER, BLUE COLOR; 9 AND 10 MILS AT FINGER, NATURAL COLOR


Device Classification Name

patient examination glove, specialty

510(k) Number K072197
Device Name POWDER-FREE LATEX EXAMINATION GLOVES – 18 MILS AT FINGER, BLUE COLOR; 9 AND 10 MILS AT FINGER, NATURAL COLOR
Applicant
METACURE SURGICAL GLOVES SDN BHD
no. 1, jln 203, off jalan
tandang
petaling jaya, 

MY

46050

Applicant Contact azman ismail
Correspondent
METACURE SURGICAL GLOVES SDN BHD
no. 1, jln 203, off jalan
tandang
petaling jaya, 

MY

46050

Correspodent Contact azman ismail
Regulation Number 880.6250
Classification Product Code
LZC  
Subsequent Product Code
LYY  
Date Received 08/07/2007
Decision Date 03/12/2008
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