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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 K221226
Device Name 1st Glove Blue Nitrile Examination Gloves Powder Free
Applicant
Koove Iot Pvt. Ltd.
Gokulpur, PO:Shyamraipur
Paschim Midnapur,  IN 721305
Applicant Contact Sudarsan Mohapatra
Correspondent
Liberty Management Group Ltd.
75 Executive Dr. STE114
Aurora,  IL  60504
Correspondent Contact Manoj Zacharias
Regulation Number880.6250
Classification Product Code
LZA  
Date Received04/28/2022
Decision Date 06/16/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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