ECO MEDI GLOVE SDN BHD

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30107632233010763223ECO MEDI GLOVE SDN BHD1N2026-01-01Lot 23826,. Jalan Tembaga Kuning Kawasan Perindustrian Kamunting Raya Taiping Perak MY 34600

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1748631486036792K233560Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric AcidLZA2024-02-26
1748631572195856K233405Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl Test ClaimLZA2023-12-28
1748631100233116K232764Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl CitrateLZA2024-02-07
1748631307601775K220943Dual Color Blue/White Powder Free Nitrile Examination Glove with Chemotherapy Drug and Fentanyl Test ClaimLZA2022-07-19
1748631356824202K193121GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs ClaimsLZA2020-03-20
1748631591358666K181066Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis claim and with tested for Use with Chemotherapy Drugs ClaimsLZA2018-09-26
1748631904985114K171339EMG Blue Nitrile Examination Gloves Powder free with tested for use with chemotherapy DrugsLZA2017-07-07
1748631287648324K161320EMG Pink Nitrile Examination Glove Powder FreeLZA2016-09-01
1748632045346868K161187EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy DrugsLZA2016-09-09
1748631565068020K152937EMG Powder Free Nitrile Examination Glove (Blue) with Peppermint ScentedLZA2016-06-23
1748631279102649K141623EMG BLUE NITRILE MEDICAL EXAMINATION GLOVE WITH CHEMOTHERAPY DRUG LABELING CLAIMLZA2014-10-07
1748631663543001K141590EMG BLUE NITRILE MEDICAL EXAMINATION GLOVE POWDER FREELZA2014-09-03
1748631227709906K141579EMG BLACK NITRILE MEDICAL EXAMINATION GLOVE POWDER FREELZA2014-10-17
1748631214091216K141510EMG WHITE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE)LZA2014-10-07
1748631913922184K032444NITRILE POWDER-FREE EXAMINATION GLOVES WITH LOTION COATING AND USE FOR CHEMOTHERAPYLZC2003-11-13
1748631056212487
1748631063130486
1748631258876935
1748631332517411
1748631354230817
1748631499081754
1748631523290893
1748631636458363
1748631763815944
1748631778381691
1748631847752211
1748631920625681

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LZA142024-02-26
LZC12003-11-13

PMN#