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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vinyl Patient Examination Glove
510(k) Number K033693
Device Name POWDER-FREE VINYL EXAMINATION GLOVES
Applicant
Shen Wei (Usa), Inc.
2845 Whipple Rd.
Union City,  CA  94587
Applicant Contact CYNTHIA LIU
Correspondent
Shen Wei (Usa), Inc.
2845 Whipple Rd.
Union City,  CA  94587
Correspondent Contact CYNTHIA LIU
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received11/24/2003
Decision Date 01/16/2004
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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