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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vinyl Patient Examination Glove
510(k) Number K003091
Device Name MEDLINE STERILE VINYL EXAM GLOVES, POWDER FREE, YELLOW
Applicant
Medline Industries, Inc.
One Medline Place
Mundelein,  IL  60060
Applicant Contact LARA N SIMMONS
Correspondent
Medline Industries, Inc.
One Medline Place
Mundelein,  IL  60060
Correspondent Contact LARA N SIMMONS
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received10/03/2000
Decision Date 10/24/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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