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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 K223235
Device Name Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs)
Applicant
PT. Sintong Unigolden Glove
Jl. Lintas Sumatera, Kel. Hessa Perlompongan,
Kec. Air Batu, Kab. Asahan
Kota Kisaran,  ID 21272
Applicant Contact MP Vivekanandan
Correspondent
Liberty Management Group Ltd.
75 Executive Dr. STE 114
Aurora,  IL  60504
Correspondent Contact Manoj Zacharias
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Code
LZC  
Date Received10/13/2022
Decision Date 10/26/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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