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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 K123869
Device Name POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES
Applicant
Dehai (Shandong) Medical Gloves, Co., Ltd.
12390 E. End Ave.
Chino,  CA  91710
Applicant Contact RAY ZHOU
Correspondent
Dehai (Shandong) Medical Gloves, Co., Ltd.
12390 E. End Ave.
Chino,  CA  91710
Correspondent Contact RAY ZHOU
Regulation Number880.6250
Classification Product Code
LZA  
Date Received12/17/2012
Decision Date 02/28/2013
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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