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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 K213306
Device Name Powder Free Nitrile Examination Gloves, Blue,Test For Use With Chemotherapy Drugs
Applicant
Zibo Sinocare Plastic Products Co., Ltd.
Lot 5, # 21 Qingtian Rd.
Zibo,  CN 255414
Applicant Contact Mila Guo
Correspondent
Zibo Sinocare Plastic Products Co., Ltd.
Lot 5, # 21 Qingtian Rd.
Zibo,  CN 255414
Correspondent Contact Mila Guo
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Code
LZC  
Date Received10/04/2021
Decision Date 02/18/2022
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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