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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 K012853
Device Name SMART GLOVE STERILE NITRILE EXAM GLOVE
Applicant
SMART GLOVE CORP. SDN BHD
LOT 6487 BATU 5 3/4
JALAN KAPAR
KLANG SELANGOR,  MY 42100
Applicant Contact NG YEW SOON
Correspondent
SMART GLOVE CORP. SDN BHD
LOT 6487 BATU 5 3/4
JALAN KAPAR
KLANG SELANGOR,  MY 42100
Correspondent Contact NG YEW SOON
Regulation Number880.6250
Classification Product Code
LZA  
Date Received08/24/2001
Decision Date 11/16/2001
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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