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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vinyl Patient Examination Glove
510(k) Number K180381
Device Name Powder Free Vinyl Patient Examination Gloves
Applicant
Shanxi Hongjin Plastic Technology Co., Ltd.
Coal Bed Gas Industrial Zone, Qu'E Town, Daning County
Linfen City,  CN 042399
Applicant Contact Wu Zhigang
Correspondent
Hongray USA Medical Products, Inc.
3973 Schaefer Ave.,
Chino,  CA  91710
Correspondent Contact Kathy Liu
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received02/12/2018
Decision Date 11/07/2018
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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