SMART SAVERS POWDER FREE NITRILE EXAMINATION GLOVE (BLUE, WHITE, PINK AND GRAY)


Device Classification Name

polymer patient examination glove

510(k) Number K080165
Device Name SMART SAVERS POWDER FREE NITRILE EXAMINATION GLOVE (BLUE, WHITE, PINK AND GRAY)
Applicant
PLATINUM GLOVE INDUSTRIES SDN.BHD.
18-22-2 jalan setia prima (q)
u13/q, setia alam u13
shah alam, selangor, 

MY

40170

Applicant Contact so soon cheaw
Correspondent
PLATINUM GLOVE INDUSTRIES SDN.BHD.
18-22-2 jalan setia prima (q)
u13/q, setia alam u13
shah alam, selangor, 

MY

40170

Correspodent Contact so soon cheaw
Regulation Number 880.6250
Classification Product Code
LZA  
Date Received 01/23/2008
Decision Date 05/14/2008
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