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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 K231643
Device Name Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
Applicant
Syntex Healthcare Products Co., Ltd.
No. 1, Fanjiazhuang Industrial Zone
Xinji,  CN 052360
Applicant Contact Qiao Zhiqiang
Correspondent
Hongray(USA) Medical Products Inc.
3973 Schaefer Avenue
Chino,  CA  91710
Correspondent Contact Liu Kathy
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Codes
LZC   OPJ   QDO  
Date Received06/05/2023
Decision Date 09/08/2023
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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