FDA.reportPublic FDA data

TG MEDICAL SDN BHD

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96806223002808366TG MEDICAL SDN BHD1N2026-01-01LOT 5091, JALAN TERATAI, BT 5 OFF JALAN MERU KLANG Selangor MY 41050

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
488261261269580K993562POWDER FREE LATEX STERILE SURGICAL GLOVESKGO1999-12-29
488261346166562K992841TG MEDICAL POWDERED NITRILE BLUE EXAMINATION GLOVESLZA1999-10-29
488261660530071K992360TG MEDICAL POWDERED NITRILE EXAMINATION GLOVESLZA1999-10-12
488261799782674K992219POWDERED LATEX STERILE SURGICAL GLOVESKGO1999-07-30
488261871077086K990668POWDER FREE BLUE NITRILE GLOVELZA1999-06-03
488261290866196K990495POWDER FREE NITRILE EXAMINATION GLOVESLZA1999-04-02
488262033249006K982872TG MEDICAL POWDER-FREE LATEX EXAMINATION GLOVE PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)LYY1998-10-15
488261116563445K941900POWDERED LATEX EXAM GLOVESLYY1994-06-21
488261771355797K262542Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder Free Examination Glove, Violet Blue Tested for Use With 32 Chemotherapy Drugs, Fentanyl & Gastric Acid Permeation Resistance ClaimLZA2026-09-09
488261425495837K260312Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim; Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric AcidLZA2026-09-08
488262030511594K250944Nitrile Powder Free Examination Glove, Blue Tested for Use with 60 Chemotherapy Drugs, Gastric Acid, Xylazine and FentanylLZA2025-04-23
488261109940212K222129Nitrile Examination Powder Free Glove, Blue Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim, Nitrile Examination Powder Free Glove, Black Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance ClaimLZA2023-02-10
488261643875312K202003Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance ClaimLZA2021-02-24
488261985284491K193150Latex Examination Powder Free Glove, Aloe VeraLZA2020-06-05
488261899806404K192111Biodegradable Nitrile Examination Powder Free Glove, GreenLZA2020-09-03
488261627182251K182382Nitrile Examination Powder Free Glove, Aloe Vera, Blue, Nitrile Examination Powder Free Glove, Aloe Vera, PinkLZC2019-08-29
488261269694064K172867Nitrile Examination Powder Free Glove, Black, Nitrile Examination Powder Free Glove, OrangeLZA2018-05-10
488261388360470K171276Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with Chemotherapy DrugsKGO2017-08-21
488261028310118K152222NITRILE BLUE POWDER FREE EXAMINATION GLOVES tested for use with Chemotheraphy DrugsLZC2016-04-21
488261780520127K113393POWDER FREE BLACK NITRILE EXAMINATION GLOVESLZA2012-09-11
488261055342712
488261379474971
488262016556761

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LZA132026-09-09
KGO32017-08-21
LZC22019-08-29
LYY21998-10-15

PMN#