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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 K182600
Device Name Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue)
Applicant
Better Care Plastic Technology Co., Ltd.
Fuqian Xi Rd., W. District Of Shenze Industrial Base,
Shenze County
Shenze County,  CN 050000
Applicant Contact Zhu Chuyan
Correspondent
Hongray USA Medical Products, Inc.
3973 Schaefer Ave., Chino, Ca 91810, Usa
Chino,  CA  91810
Correspondent Contact Kathy Liu
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Code
LZC  
Date Received09/21/2018
Decision Date 11/30/2018
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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