POWDER FREE STERILE LATEX EXAM RADIATION ATTENUATION GLOVES


Device Classification Name

patient examination glove, specialty

510(k) Number K121811
Device Name POWDER FREE STERILE LATEX EXAM RADIATION ATTENUATION GLOVES
Applicant
SHEN WEI (USA), INC.
33278 central ave.,
suite 102
union city, 
CA 
94587

Applicant Contact albert li
Correspondent
SHEN WEI (USA), INC.
33278 central ave.,
suite 102
union city, 
CA 
94587

Correspodent Contact albert li
Regulation Number 880.6250
Classification Product Code
LZC  
Date Received 06/20/2012
Decision Date 11/21/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

Radiology

Type Traditional
Reviewed by Third Party No

Combination Product

No