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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 K171460
Device Name Powder-free Clear Vinyl Patient Examination Gloves
Applicant
Shandong Zhiwei Medical Products, Co. , Ltd.
# 4519 Qingzhou Rd.
Qingzhou,  CN 255000
Applicant Contact Carrie Wu
Correspondent
Intco Medical Industries, Inc.
805 Barrington Ave.
Ontario,  CA  91764
Correspondent Contact Melo Zhang
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received05/18/2017
Decision Date 09/24/2017
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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