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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K161074
Device Name Powder Free Nitrile Examination Gloves Flock-Lined, Black Color
Applicant
Shen Wei (Usa), Inc.
33278 Central Ave.
Suite 102
Union City,  CA  94587
Applicant Contact CHERYL BAILEY-KROLL
Correspondent
Shen Wei (Usa), Inc.
33278 Central Ave.
Suite 102
Union City,  CA  94587
Correspondent Contact CHERYL BAILEY-KROLL
Regulation Number880.6250
Classification Product Code
LZA  
Date Received04/18/2016
Decision Date 11/17/2016
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
Predetermined Change
Control Plan Authorized		 No
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