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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 K892575
Device Name VINYL PATIENT EXAMINATION GLOVES
Applicant
FOODHANDLER, INC.
514 GRAND BLVD.
WESTBURY,  NY  11590
Applicant Contact SOL MENDELSOHN
Correspondent
FOODHANDLER, INC.
514 GRAND BLVD.
WESTBURY,  NY  11590
Correspondent Contact SOL MENDELSOHN
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received04/10/1989
Decision Date 07/24/1989
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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