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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 K163126
Device Name Powder Free Nitrile Examination Gloves (Blue, White, Black, Violet Blue, Cobalt blue)
Applicant
Blue Sail Medical Co.,Ltd
# 21 Qingtian Rd., Qilu Chemical Industrial Park
Zibo,  CN 255414
Applicant Contact Robin Liu
Correspondent
Blue Sail Medical Co.,Ltd
# 21 Qingtian Rd.
Qilu Chemical Industrial Park
Zibo,  CN 255414
Correspondent Contact Robin Liu
Regulation Number880.6250
Classification Product Code
LZA  
Date Received11/08/2016
Decision Date 02/22/2017
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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