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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgeon'S Gloves
510(k) Number K171047
Device Name Sterile Polyisoprene Powder Free Surgical Gloves
Applicant
Better Care Plastic Technology Co., Ltd.
Fuqian Xi Rd., W. District Of Shenze Industrial Base
Shenze County,  CN 050000
Applicant Contact Zhu Chunyan
Correspondent
Hongray USA Medical Products, Inc.
2235 E Francis St.
Ontario,  CA  91761
Correspondent Contact Kathy Liu
Regulation Number878.4460
Classification Product Code
KGO  
Date Received04/07/2017
Decision Date 06/22/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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