POWDER FREE NITRILE EXAMINATION GLOVES WHITE COLORED NON-STERILE


Device Classification Name

polymer patient examination glove

510(k) Number K103734
Device Name POWDER FREE NITRILE EXAMINATION GLOVES WHITE COLORED NON-STERILE
Applicant
CENTRAL MEDICARE SDN BHD
1930 brea canyon road,
#240,diamond bar
diamond bar, 
CA 
91765

Applicant Contact nick wang
Correspondent
CENTRAL MEDICARE SDN BHD
1930 brea canyon road,
#240,diamond bar
diamond bar, 
CA 
91765

Correspodent Contact nick wang
Regulation Number 880.6250
Classification Product Code
LZA  
Date Received 12/22/2010
Decision Date 08/19/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No