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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 K231567
Device Name Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and select other drugs (Blue)
Applicant
Better Care Plastic Technology Co., Ltd.
Fuqian Xi Road, West district of Shenze Industrial Base
Shenze County,  CN 050000
Applicant Contact Zhu Chunyan
Correspondent
Hongray(USA) Medical Products Inc.
3973 Schaefer Avenue
Chino,  CA  91710
Correspondent Contact Kathy Liu
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Codes
LZC   OPJ   QDO  
Date Received05/31/2023
Decision Date 10/04/2023
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
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