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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 K895637
Device Name LATEX EXAM GLOVES (MFG. SUPER GLOVE INDUSTRY CO.)
Applicant
Transcontinental Fertilizer Co.
220 S. 16th St., 5th
Floor
Philadelphia,  PA  19102
Applicant Contact ALFRED W ASPEN
Correspondent
Transcontinental Fertilizer Co.
220 S. 16th St., 5th
Floor
Philadelphia,  PA  19102
Correspondent Contact ALFRED W ASPEN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received09/19/1989
Decision Date 12/11/1989
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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