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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 K213912
Device Name Disposable Medical Nitrile Examination Gloves
Applicant
Jiangsu Maolin Medical Technology Co., Ltd.
29 Yuexiang Rd., Yuecheng Town
Jiangyin,  CN 214404
Applicant Contact Yuan Mao
Correspondent
Jiangsu Maolin Medical Technology Co., Ltd.
29 Yuexiang Rd., Yuecheng Town
Jiangyin,  CN 214404
Correspondent Contact Yuan Mao
Regulation Number880.6250
Classification Product Code
LZA  
Date Received12/15/2021
Decision Date 02/19/2022
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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