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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
Predetermined Change
Control Plan Authorized		 No
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