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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K100211
Device Name PEARLSCENT BLACK TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES, COATED WITH ALOE VERA
Applicant
Shen Wei (Usa), Inc.
33278 Central Ave.
Suite 102
Union City,  CA  94587
Applicant Contact BELLE CHOU
Correspondent
Shen Wei (Usa), Inc.
33278 Central Ave.
Suite 102
Union City,  CA  94587
Correspondent Contact BELLE CHOU
Regulation Number880.6250
Classification Product Code
LYY  
Date Received01/25/2010
Decision Date 05/11/2010
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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