FDA.reportPublic FDA data

KOON SENG SDN BHD

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30085091763008509176KOON SENG SDN BHD1N2026-01-01PTD16058, Kawasan Perindustrian Tangkak Jalan Muar Tangkak Johor MY 84900

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1973011457447621K212613Powder Free Nitrile Examination Gloves, Non-sterile,Tested For Use with Chemotherapy Drugs and Opioid Fentanyl Citrate (Blue)LZA2021-12-21
1973011701512336K171171KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (Blue, Black)LZA2018-02-22
1973011150110697K110960ROYAL IMPERIAL NITRILE EXAMINATION GLOVES TEXTURED POWDER-FREELZA2011-07-14
1973011716838837K093375KS-CARE POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50UG OR LESS)LYY2009-12-02
1973011278074558K013537ROYAL IMPERIAL POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)LYY2001-12-07
1973011641334901K012714ROYAL IMPERIAL POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS ORLYY2001-10-31
1973011486082355
1973011494455707
1973011618124685
1973011627011604
1973011688549849

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LZA32021-12-21
LYY32009-12-02

PMN#