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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 K223713
Device Name Powder Free Nitrile Examination Glove (Grey) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Applicant
Better Care Plastic Technology Co., Ltd.
Fuqian Xi Rd., W. District Of Shenze Industrial Base
Shenze County,  CN 050000
Applicant Contact Zhu Chunyan
Correspondent
Hongray USA Medical Products, Inc.
3973 Schaefer Ave.,
Chino,  CA  91710
Correspondent Contact Kathy Liu
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Codes
LZC   OPJ   QDO  
Date Received12/12/2022
Decision Date 08/07/2023
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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