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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 K221229
Device Name Powder Free Nitrile Examination Gloves, (Cobalt Blue and Violet Blue), Powder Free Latex Examination Gloves
Applicant
Zibo Blue Sail Health Technology Co., Ltd.
#1888 Honghua Rd., High Technical Area
Zibo,  CN 255400
Applicant Contact Xu Shulong
Correspondent
Zibo Blue Sail Health Technology Co., Ltd.
#1888 Honghua Rd., High Technical Area
Zibo,  CN 255400
Correspondent Contact Xu Shulong
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Code
LYY  
Date Received04/29/2022
Decision Date 07/16/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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