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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 K090568
Device Name MEDLINE NITRILE EXAM GLOVES W/ALOE -GREEN
Applicant
Medline Industries, Inc.
One Medline Pl.
Mundelein,  IL  60060
Applicant Contact MATT CLAUSEN
Correspondent
Medline Industries, Inc.
One Medline Pl.
Mundelein,  IL  60060
Correspondent Contact MATT CLAUSEN
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Code
LZC  
Date Received03/03/2009
Decision Date 10/02/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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