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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 K101594
Device Name POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE
Applicant
Better Care Plastic Technology Cp., Ltd.
3973 Schaefer Ave.,
Chino,  CA  91710
Applicant Contact JIE LIU\
Correspondent
Better Care Plastic Technology Cp., Ltd.
3973 Schaefer Ave.,
Chino,  CA  91710
Correspondent Contact JIE LIU\
Regulation Number880.6250
Classification Product Code
LZA  
Date Received06/08/2010
Decision Date 10/08/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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