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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 K211604
Device Name Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs
Applicant
Shanxi Hongjin Plastic Technology Co., Ltd.
Coal Bed Gas Industrial Zone, Qu'e Town, Daning County
Lifen,  CN 042300
Applicant Contact Wu Zhigang
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 Code
LZC  
Date Received05/25/2021
Decision Date 10/27/2021
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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