FDA.reportPublic FDA data

KOON SENG SDN.BHD

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
80407933003218972KOON SENG SDN.BHD1N2020-04-25PTD 3274 BATU 4 1/2 JALAN BAKRI MUAR Johor MY 84000

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
417471150110697K110960ROYAL IMPERIAL NITRILE EXAMINATION GLOVES TEXTURED POWDER-FREELZA2011-07-14
417471486082355K110921NITRILE POWDER-FREE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGSLZA2011-04-15
417471716838837K093375KS-CARE POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50UG OR LESS)LYY2009-12-02
417471494455707K022765NITRILE POWDER-FREE EXAMINATION GLOVESLZA2002-10-11
417471278074558K013537ROYAL IMPERIAL POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)LYY2001-12-07
417471641334901K012714ROYAL IMPERIAL POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS ORLYY2001-10-31

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LZA32011-07-14
LYY32009-12-02

PMN#