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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 K040792
Device Name POLYMER COATED, POWDER FREE LATEX EXAMINATION GLOVE (WHITE)
Applicant
Pt. Smartglove Indonesia
Kawasan Industri Medan Star J1
Raya Medan-Lubuk Pakam Km.19
Tg Morawa-Deli Serdang Utara,  ID 20362
Applicant Contact FOO KHON PU
Correspondent
Pt. Smartglove Indonesia
Kawasan Industri Medan Star J1
Raya Medan-Lubuk Pakam Km.19
Tg Morawa-Deli Serdang Utara,  ID 20362
Correspondent Contact FOO KHON PU
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/29/2004
Decision Date 08/12/2004
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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