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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 K013794
Device Name POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE AND PROTEIN CLAIM, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
Applicant
Shen Wei (Usa), Inc.
2845 Whipple Rd.
Union City,  CA  94587
Applicant Contact BELLE L CHOU
Correspondent
Shen Wei (Usa), Inc.
2845 Whipple Rd.
Union City,  CA  94587
Correspondent Contact BELLE L CHOU
Regulation Number880.6250
Classification Product Code
LYY  
Date Received11/14/2001
Decision Date 01/22/2002
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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