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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 K152712
Device Name Nitrile Powder Free Patient Examination Gloves, Blue Color
Applicant
Zhonghong Pulin Medical Products Co., Ltd.
Pachigang Industrial Park, Luannan County
Tangshan,  CN 063502
Applicant Contact LI Jinge
Correspondent
Chu Xiaoan
Rm. 1606 Bldg. 1. Jianxiang Yuan # 209
Bei Si Huan Zhong Rd., Haidian Dis
Beijing,  CN 100083
Correspondent Contact Chu Xiaoan
Regulation Number880.6250
Classification Product Code
LZA  
Date Received09/21/2015
Decision Date 03/09/2016
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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