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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 K121526
Device Name POWER-FREE NITRILE PATIENT EXAMINATION GLOVES
Applicant
Shandong Junchi Medical Products Co., Ltd.
12390 E. End Ave.
Chino,  CA  91710
Applicant Contact CECILY SHENG
Correspondent
Shandong Junchi Medical Products Co., Ltd.
12390 E. End Ave.
Chino,  CA  91710
Correspondent Contact CECILY SHENG
Regulation Number880.6250
Classification Product Code
LZA  
Date Received05/23/2012
Decision Date 08/03/2012
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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