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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 K192933
Device Name Polyisoprene Powder Free, Black Colour Surgical Gloves
Applicant
Emerson & Co. Srl
Piazza Della Vittoria 10
Genoa,  IT 16121
Applicant Contact Laura Figliomeni
Correspondent
Emerson & Co. Srl
Piazza Della Vittoria 10
Genoa,  IT 16121
Correspondent Contact Laura Figliomeni
Regulation Number878.4460
Classification Product Code
KGO  
Date Received10/17/2019
Decision Date 01/13/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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