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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 K011045
Device Name TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM
Applicant
Shen Wei (Usa), Inc.
2845 Whipple Rd.
Union City,  CA  94587
Applicant Contact BELLE CHOU
Correspondent
Shen Wei (Usa), Inc.
2845 Whipple Rd.
Union City,  CA  94587
Correspondent Contact BELLE CHOU
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/05/2001
Decision Date 09/11/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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