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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 K891648
Device Name GOLD CLASS, GRANDTEX, LATEX EXAMINATION GLOVES
Applicant
Harry Panzer Intl. Corp.
275, Halstead Ave.
Harrison,  NY  10528
Applicant Contact HARRY PANZER
Correspondent
Harry Panzer Intl. Corp.
275, Halstead Ave.
Harrison,  NY  10528
Correspondent Contact HARRY PANZER
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/17/1989
Decision Date 04/07/1989
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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