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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)
Better Care Plastic Technology Co., Ltd
Fuqian Xi Road, West district of Shenze Industrial Base,
Shenze County
Shenze County,  CN 050000
Applicant Contact Zhu Chuyan
Hongray USA Medical Products Inc
3973 Schaefer Avenue, Chino, CA 91810, USA
Chino,  CA  91810
Correspondent Contact Kathy Liu
Regulation Number880.6250
Classification Product Code
Subsequent Product Code
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