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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 K901148
Device Name LATEX EXAMINATION GLOVES
Applicant
Pt. Scitech Industries
80. Kav.O.J1 Garuda
Jakarta 10620
Indonesia,  ID
Applicant Contact GUSTAV A HUSEIN
Correspondent
Pt. Scitech Industries
80. Kav.O.J1 Garuda
Jakarta 10620
Indonesia,  ID
Correspondent Contact GUSTAV A HUSEIN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/12/1990
Decision Date 04/09/1990
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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