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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 K923967
Device Name PATIENT EXAM GLOVES (POWDER FREE)
Applicant
American Health Products, Inc.
3330 Dundee Rd., S4
North Brook,  IL  60062
Applicant Contact EDWARD J MARTEKA
Correspondent
American Health Products, Inc.
3330 Dundee Rd., S4
North Brook,  IL  60062
Correspondent Contact EDWARD J MARTEKA
Regulation Number880.6250
Classification Product Code
LYY  
Date Received08/06/1992
Decision Date 12/15/1992
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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