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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 K021013
Device Name SMART GLOVE STERILE NITRILE EXAMINATION GLOVES (POWDERED FREE)
Applicant
Smart Glove Corp. Sdn Bhd
Lot 6487, Batu 5 3/4
Sementa, Jalan Kapar
Klang, Selangor,  MY 42100
Applicant Contact NG YEW SOON
Correspondent
Smart Glove Corp. Sdn Bhd
Lot 6487, Batu 5 3/4
Sementa, Jalan Kapar
Klang, Selangor,  MY 42100
Correspondent Contact NG YEW SOON
Regulation Number880.6250
Classification Product Code
LZA  
Date Received03/29/2002
Decision Date 05/22/2002
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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