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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgeon'S Gloves
510(k) Number K190632
Device Name Latex Surgeon’s Gloves Powder Free with protein content labeling claim of 50µg/dm2 or less per glove of extractable protein
Applicant
Lenora Glove PVT LTD.
Plot No: 15/104-1, Rottigoundanur, Thirumalayampalayam P.O.
Coimbatore,  IN 641105
Applicant Contact Antony Kurian
Correspondent
Liberty Management Group Ltd.
75 Executive Drive
STE 114
Aurora,  IL  60504
Correspondent Contact Manoj Zacharias
Regulation Number878.4460
Classification Product Code
KGO  
Date Received03/12/2019
Decision Date 10/24/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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