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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 K081466
Device Name STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
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 Received05/27/2008
Decision Date 07/30/2008
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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