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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 K120970
Device Name NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, COLORED (BLUE)
Applicant
Tangshan Zhonghong Pulin Plastic Co.,Ltd
Rm.1606 Bldg. 1
Jianxiang Yuan #209 Bei Shi Huan Zho
Beijing,  CN CH
Applicant Contact CHU XIAOAN
Correspondent
Tangshan Zhonghong Pulin Plastic Co.,Ltd
Rm.1606 Bldg. 1
Jianxiang Yuan #209 Bei Shi Huan Zho
Beijing,  CN CH
Correspondent Contact CHU XIAOAN
Regulation Number880.6250
Classification Product Code
LZA  
Date Received03/30/2012
Decision Date 07/19/2012
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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