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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 K101630
Device Name POWDER FREE NITRILE EXAMINATION GLOVES (6MIL), TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE
Applicant
Pt. Smartglove Indonesia
Jl Raya Medan-Lubuk Pakam Km19
Tanjong Morawa B,Tanjong
Morawa,Deli Serdang,Sumatera U,  ID 20362
Applicant Contact CHO SOW FONG
Correspondent
Pt. Smartglove Indonesia
Jl Raya Medan-Lubuk Pakam Km19
Tanjong Morawa B,Tanjong
Morawa,Deli Serdang,Sumatera U,  ID 20362
Correspondent Contact CHO SOW FONG
Regulation Number880.6250
Classification Product Code
LZA  
Date Received06/10/2010
Decision Date 09/07/2010
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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