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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 K894480
Device Name PATIENT EXAMINATION GLOVES
Applicant
Pt. Intan Hevea Industry
Jl. K.L. Yos Sudarso K.M. 9.5
(Kp. Mabar)
Medan - Indonesia,  ID
Applicant Contact MANSUR TANDJO
Correspondent
Pt. Intan Hevea Industry
Jl. K.L. Yos Sudarso K.M. 9.5
(Kp. Mabar)
Medan - Indonesia,  ID
Correspondent Contact MANSUR TANDJO
Regulation Number880.6250
Classification Product Code
LYY  
Date Received07/18/1989
Decision Date 09/15/1989
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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