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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K914498
Device Name POWDER FREE, NON-STERILE, LATEX EXAMINATION GLOVES
Applicant
Medmark, Inc.
800 Ironwood
Olathe,  KS  66061
Applicant Contact MARJORIE SKINNER
Correspondent
Medmark, Inc.
800 Ironwood
Olathe,  KS  66061
Correspondent Contact MARJORIE SKINNER
Regulation Number880.6250
Classification Product Code
LYY  
Date Received10/08/1991
Decision Date 11/27/1991
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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