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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 K221108
Device Name Nitrile Medical Examination Gloves
Applicant
Anhui Fulewei Electronic Technology Co.,Ltd
South Of Binheroad, W. Of Gangkou Rd.,
Economic Development Zone,
Fuyang,  CN 236000
Applicant Contact Beina Gong
Correspondent
Anhui Fulewei Electronic Technology Co.,Ltd
South Of Binheroad, W. Of Gangkou Rd.,
Economic Development Zone,
Fuyang,  CN 236000
Correspondent Contact Beina Gong
Regulation Number880.6250
Classification Product Code
LZA  
Date Received04/15/2022
Decision Date 07/12/2022
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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