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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 K220229
Device Name Powder Free Nitrile Examination Gloves, Orange
Shanxi Hongjin Plastic Technology Co., Ltd.
Coal Bed Gas Industrial Zone, Qu'e Town, Daning County
Linfen,  CN 042300
Applicant Contact Wu Zhigang
Hongray USA Medical Products Inc.
3973 Schaefer Avenue
Chino,  CA  91710
Correspondent Contact Kathy Liu
Regulation Number880.6250
Classification Product Code
Date Received01/27/2022
Decision Date 03/26/2022
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