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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 K910631
Device Name SUNTEX STERILE EXAM GLOVES
Applicant
P.T. LATEXINDO PRAUTAMA
C/O TRANSCORP
40 DOGWOOD DRIVE
chester,  NJ  07930
Applicant Contact robert s kennedy
Correspondent
P.T. LATEXINDO PRAUTAMA
C/O TRANSCORP
40 DOGWOOD DRIVE
chester,  NJ  07930
Correspondent Contact robert s kennedy
Regulation Number880.6250
Classification Product Code
LYY  
Date Received02/13/1991
Decision Date 03/07/1991
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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