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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 K221192
Device Name Disposable Nitrile Powder-Free Examination Gloves
Applicant
Shandong Maida Medical Technology Co., Ltd.
Rm. 102, Eastern Bldg., #166
South 1st Rd., Development Zone
Dongying,  CN 257000
Applicant Contact Kitty Xu
Correspondent
Shanghai Truthful Information Technology Co., Ltd.
Rm.608,# 738,Shangcheng Rd., Pudong
Shanghai,  CN 200120
Correspondent Contact Boyle Wang
Regulation Number880.6250
Classification Product Code
LZA  
Date Received04/25/2022
Decision Date 06/22/2022
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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