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FDA 510(k) Application Details - K123328
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K123328
Device Name
Polymer Patient Examination Glove
Applicant
NITRILIST GLOVES MANUFACTURING SDN BHD
PT 197, KAWASAN PERINDUSTRIAN DIOH
KUALA PILAH 72000 MY
Other 510(k) Applications for this Company
Contact
LAU SIONG HUT
Other 510(k) Applications for this Contact
Regulation Number
880.6250
More FDA Info for this Regulation Number
Classification Product Code
LZA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/22/2012
Decision Date
01/18/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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