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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 K090194
Device Name POWDER- FREE NITRILE EXAMINATION GLOVES, BLACK COLOR
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
LZA  
Date Received01/27/2009
Decision Date 07/07/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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