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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 K950823
Device Name ANDAL
Applicant
Pt. Sarana Indoprotex
I.R. Sutami Km 07
Bandar Lampung 35001
Indonesia,  ID
Correspondent
Pt. Sarana Indoprotex
I.R. Sutami Km 07
Bandar Lampung 35001
Indonesia,  ID
Regulation Number880.6250
Classification Product Code
LYY  
Date Received02/23/1995
Decision Date 05/10/1995
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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