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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 K062067
Device Name TEXTURED POWER FREE BP2000 (BUTADIENE POLYMER) EXAM GLOVES, NATURAL COLOR
Applicant
Shen Wei (Usa), Inc.
33278 Central Ave.
Suite 102
Union City,  CA  94587
Applicant Contact CYNTHIA LIU
Correspondent
Shen Wei (Usa), Inc.
33278 Central Ave.
Suite 102
Union City,  CA  94587
Correspondent Contact CYNTHIA LIU
Regulation Number880.6250
Classification Product Code
LZA  
Date Received07/21/2006
Decision Date 09/06/2006
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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