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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 K993811
Device Name MULTISAFE POWDERED LATEX EXAMINATION GLOVES, NONSTERILE
Applicant
Multisafe Sdn. Bhd.
Lot 764
Bidor Industrial Estate
35500 Bidor, Perak Darul Ridzu,  MY 35500
Applicant Contact GOH SEOK HUEI
Correspondent
Multisafe Sdn. Bhd.
Lot 764
Bidor Industrial Estate
35500 Bidor, Perak Darul Ridzu,  MY 35500
Correspondent Contact GOH SEOK HUEI
Regulation Number880.6250
Classification Product Code
LYY  
Date Received11/10/1999
Decision Date 03/02/2000
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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