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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 K171873
Device Name Powder Free Nitrile Patient Examination Glove, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs
Applicant
Zhonghong Pulin Medical Products Co., Ltd.
Pachigang Industrial Park, Luannan County
Tangshan,  CN 063502
Applicant Contact Jinge Li
Correspondent
Zhonghong Pulin Medical Products Co., Ltd.
800 - 10 Four Seasons Place
Toronto,  CA M9B 6H7
Correspondent Contact Da Shi
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Code
LZC  
Date Received06/23/2017
Decision Date 11/15/2017
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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