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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 K974853
Device Name LATEX (POWDER FREE) LOW PROTEIN
Applicant
P.T. Healthcare Glovindo
Jalan Kebun Sirih 39
Jakarta,  ID 10340
Applicant Contact ELLEN HUTAPEA
Correspondent
P.T. Healthcare Glovindo
Jalan Kebun Sirih 39
Jakarta,  ID 10340
Correspondent Contact ELLEN HUTAPEA
Regulation Number880.6250
Classification Product Code
LYY  
Date Received12/29/1997
Decision Date 02/09/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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