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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 K171898
Device Name Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With Chemotherapy Drugs
Better Care Plastic Technology Co., Ltd
Fuqian Xi Road, West district of Shenze Industrial Base
Shenze County,  CN 050000
Applicant Contact Zhu Chunyan
Hongray USA Medical Products Inc
2235 E Francis St
Ontario,  CA  91761
Correspondent Contact Kathy Liu
Regulation Number878.4460
Classification Product Code
Date Received06/26/2017
Decision Date 08/18/2017
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