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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name medical 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
Correspondent Contact ALBERT LI
Regulation Number880.6250
Classification Product Code
LZC  
Date Received06/20/2012
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
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