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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 K202449
Device Name Signature Latex LT, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50µg/dm² per glove of Extractable Protein
Applicant
Medline Industries, Inc.
Three Lakes Dr.
Northfiled,  IL  60093
Applicant Contact Jennifer Mason
Correspondent
Medline Industries, Inc.
Three Lakes Dr.
Northfiled,  IL  60093
Correspondent Contact Jennifer Mason
Regulation Number878.4460
Classification Product Code
KGO  
Subsequent Product Code
LZC  
Date Received08/26/2020
Decision Date 11/18/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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