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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgeon'S Gloves
510(k) Number K113233
Device Name POWDERED LATEX SURGICAL GLOVES STERILE, STERILE WITH PROTEIN CONTENT LABELING CLAIM
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 Number878.4460
Classification Product Code
KGO  
Date Received11/02/2011
Decision Date 03/29/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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