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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 K092034
Device Name POWDER FREE NITRILE EXAMINATION GLOVES, BLACK
Applicant
Pt. Smartglove Indonesia
Jl Raya Medan-Lubuk Pakam Km19
Tanjong Morawa B,Tanjong
Morawa,Deli Serdang,Sumatera U,  ID 20362
Applicant Contact SOON TUCK KWAN
Correspondent
Pt. Smartglove Indonesia
Jl Raya Medan-Lubuk Pakam Km19
Tanjong Morawa B,Tanjong
Morawa,Deli Serdang,Sumatera U,  ID 20362
Correspondent Contact SOON TUCK KWAN
Regulation Number880.6250
Classification Product Code
LZA  
Date Received07/06/2009
Decision Date 10/19/2009
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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