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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 K943620
Device Name MICRO-TOUCH LATEX MEDICAL GLOVES
Applicant
JOHNSON & JOHNSON MEDICAL, INC.
2500 ARBROOK BLVD.
P.O. BOX 90130
ARLINGTON,  TX  76004 -0130
Applicant Contact RALPH H LARSEN
Correspondent
JOHNSON & JOHNSON MEDICAL, INC.
2500 ARBROOK BLVD.
P.O. BOX 90130
ARLINGTON,  TX  76004 -0130
Correspondent Contact RALPH H LARSEN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received07/27/1994
Decision Date 09/09/1994
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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