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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 K182640
Device Name Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Blue and Violet Blue)
Applicant
Shandong Hengya Packaging Printing Co.,Ltd
Hetou Village, Yingqiu Town, Changle County,
Weifang City,  CN 262416
Applicant Contact Sunny Hu
Correspondent
Shandong Hengya Packaging Printing Co.,Ltd
Hetou Village, Yingqiu Town, Changle County,
Weifang City,  CN 262416
Correspondent Contact Sunny Hu
Regulation Number880.6250
Classification Product Code
LZA  
Date Received09/24/2018
Decision Date 04/12/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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