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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K890592
Device Name PATIENT EXAMINATION GLOVE
Applicant
Alfaseal Sdn. Bhd.
Lot 6128, Jalan Salleh, Batu
5, Jalan
Meru Klang Sl,  MY 41050
Applicant Contact CHIN WOO
Correspondent
Alfaseal Sdn. Bhd.
Lot 6128, Jalan Salleh, Batu
5, Jalan
Meru Klang Sl,  MY 41050
Correspondent Contact CHIN WOO
Regulation Number880.6250
Classification Product Code
LYY  
Date Received02/06/1989
Decision Date 05/22/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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