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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 K050122
Device Name POWDER FREE NITRILE EXAMINATION GLOVE (BLUE) (THIS PRODUCT DOES NOT CONTAIN THIURAM, AND/OR CARBAMATE AND/OR THIAZOLE)
Applicant
SMART GLOVE CORP. SDN BHD
LOT 6487 BATU 5 3/4
JALAN KAPAR
KLANG SELANGOR,  MY 42100
Applicant Contact FOO KHON PU
Correspondent
SMART GLOVE CORP. SDN BHD
LOT 6487 BATU 5 3/4
JALAN KAPAR
KLANG SELANGOR,  MY 42100
Correspondent Contact FOO KHON PU
Regulation Number880.6250
Classification Product Code
LZA  
Date Received01/19/2005
Decision Date 04/18/2005
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
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