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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K944778
Device Name LATEX EXAMINATION GLOVES
Applicant
Pt. Haloni Jane
8-I, Jalan Kapten Maulana
Lubis Dalam
Medan,  ID 20112
Applicant Contact LIPINY KUWANTO
Correspondent
Pt. Haloni Jane
8-I, Jalan Kapten Maulana
Lubis Dalam
Medan,  ID 20112
Correspondent Contact LIPINY KUWANTO
Classification Product Code
OPE
Date Received09/27/1994
Decision Date 11/17/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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