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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 K980605
Device Name LOW PROTEIN LATEX PATIENT EXAMINATION GLOVES (POWDER-FREE)
Applicant
Pt. Sarana Indoprotex
Jalan Ir. Sutami Km. 7
Lematang
Bandar, Lampung,  ID 35001
Applicant Contact ELLEN HUTAPEA
Correspondent
Pt. Sarana Indoprotex
Jalan Ir. Sutami Km. 7
Lematang
Bandar, Lampung,  ID 35001
Correspondent Contact ELLEN HUTAPEA
Regulation Number880.6250
Classification Product Code
LYY  
Date Received02/17/1998
Decision Date 04/14/1998
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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