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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K992177
Device Name NITRILE EXAMINATION GLOVES- PRE-POWDERED, SMALL, MEDIUM, AND LARGE
Applicant
Pt. Berlian Glovindo
Jln. Raya Medan Rantau Prapat
Km +230 Desa Damuli
Kec. Labuhan Batu - N. Sumatra,  ID
Applicant Contact TONY JAP
Correspondent
Pt. Berlian Glovindo
Jln. Raya Medan Rantau Prapat
Km +230 Desa Damuli
Kec. Labuhan Batu - N. Sumatra,  ID
Correspondent Contact TONY JAP
Regulation Number880.6250
Classification Product Code
LZA  
Date Received06/28/1999
Decision Date 07/29/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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