Eco Medi Glove Sdn Bhd

FDA Filings

This page includes the latest FDA filings for Eco Medi Glove Sdn Bhd. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3010763223
FEI Number3010763223
NameDavid Lennarz
Owner & OperatorECO Medi Glove SDN BHD
Contact AddressLot 23826,. Jalan Tembaga Kuning Kawasan Perindustrian Kamunting Raya
Taiping MY-08 Perak 34600 MY
US Agent
Importing Logistics Registration
ImporterHenry Shein, Inc
Address135 Duryea Rd
Melville, NY 11747 UNITED STATES
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address144 Research Drive
Hampton, VA 23666 US
Establishment Type
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)



Registration Number3016413634
FEI Number3016413634
NameECO MEDI GLOVE SDN BHD
Owner & OperatorEco Medi Glove Sdn Bhd
Contact AddressLot 26910, Lorong Perusahaan 3/3 Kawasan Perusahaan, Kamunting Raya
Taiping MY-08 Perak 34600 MY
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressLot 26910, Lorong Perusahaan 3/3 Kawasan Perusahaan, Kamunting Raya
Taiping Perak, 34600 MY
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
ECO Medi Glove Sdn. Bhd
Powder Free NR Latex Surgical Glove (Sterile) With Protein Content Labelling Claims 50ug/dm2 Or Less Per Glove Of Extractable Protein2021-02-17
ECO Medi Glove SDN BHD
GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim And With Tested For Use With Chemotherapy Drugs Claims2020-03-20
ECO MEDI GLOVE SDN BHD
Surgical Latex Glove2019-10-30
ECO MEDI GLOVE SDN BHD
Latex Glove2019-10-30
ECO MEDI GLOVE SDN BHD
Examination Glove2019-10-30
ECO MEDI GLOVE SDN BHD
Surgical Latex Glove2019-10-30
ECO MEDI GLOVE SDN BHD
Latex Glove2019-10-30
ECO MEDI GLOVE SDN BHD
Examination Glove2019-10-30
ECO Medi Glove Sdn Bhd
Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Claim And With Tested For Use With Chemotherapy Drugs Claims2018-09-26
ECO MEDI GLOVE SDN. BHD
EMG Blue Nitrile Examination Gloves Powder Free With Tested For Use With Chemotherapy Drugs2017-07-07
ECO MEDI GLOVE SDN BHD
EMG Blue Nitrile Examination Gloves Powder Free With Tested For Use With Chemotherapy Drugs2016-09-09
David Lennarz [ECO Medi Glove SDN BHD]
EMG Pink Nitrile Examination Glove Powder Free2016-09-09
David Lennarz [ECO Medi Glove SDN BHD]
EMG Blue Nitrile Examination Glove Powder Free with tested for used with Chemotherapy Drugs2016-09-09
David Lennarz [ECO Medi Glove SDN BHD]
EMG Blue Nitrile Examination Glove Powder Free with tested for used with Chemotherapy Drugs2016-09-09
ECO MEDI GLOVE SDN. BHD.
EMG Pink Nitrile Examination Glove Powder Free2016-09-01
David Lennarz [ECO Medi Glove SDN BHD]
EMG Powder Free Nitrile Examination (Blue) Glove with Peppermint Scented2016-06-24
ECO MEDI GLOVE SDN. BHD.
EMG Powder Free Nitrile Examination Glove (Blue) With Peppermint Scented2016-06-23
ECO MEDI GLOVE SDN. BHD
EMG BLACK NITRILE MEDICAL EXAMINATION GLOVE POWDER FREE2014-10-17
ECO MEDI GLOVE SDN BHD
EMG BLUE NITRILE MEDICAL EXAMINATION GLOVE WITH CHEMOTHERAPY DRUG LABELING CLAIM2014-10-07
ECO MEDI GLOVE SDN. BHD
EMG WHITE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE)2014-10-07
David Lennarz [ECO Medi Glove SDN BHD]
Blue Nitrile Examination Gloves Powder free with tested for use with Chemotherapy Drugs Labeling Claim2014-10-07
David Lennarz [ECO Medi Glove SDN BHD]
White Nitrile Examination Gloves Powder Free2014-10-07
David Lennarz [ECO Medi Glove SDN BHD]
Showa N-DEX 6050PF;Showa N-DEX 8050PF;Showa N-DEX 9950PF;Showa N-DEX B6050PF;Showa N-DEX B9950PF2014-10-03
David Lennarz [ECO Medi Glove SDN BHD]
EMG Blue Nitrile Medical Examination Glove Powder Free (Non-Sterile)2014-10-03
ECO MEDI GLOVE SDN. BHD
EMG BLUE NITRILE MEDICAL EXAMINATION GLOVE POWDER FREE2014-09-03

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
202009141605Suez,Egypt -> Savannah, GeorgiaGLOVES #6050PF 4 MILS/240MM /BLUE1350 CTN
202009053789Suez,Egypt -> New York, New YorkGLOVES #6050PF 4 MILS/240MM /BLUE1350 CTN
202008287108Singapore,Singapore -> Houston, Texas1 X 40HQ CONTAINER CONTAINING :- 3,500 CASES OF POWDER FREE NITRILE EXAM GLOVES - CORNFLOWER BLUE AS PER PURCHASE ORDER NO.4267 . 1 X 20GP CONTAINER CONTAINING :-5240 CAS
202008287108Singapore,Singapore -> Houston, Texas1 X 40HQ CONTAINER CONTAINING :- 3,500 CASES OF POWDER FREE NITRILE EXAM GLOVES - CORNFLOWER BLUE AS PER PURCHASE ORDER NO.4267 . 1 X 20GP CONTAINER CONTAINING :-5240 CAS
2020081728030Singapore,Singapore -> New York/Newark Area, Newark, New JerseyFURNITURE1760 CAS
2020081213684Singapore,Singapore -> Houston, TexasPOWDER FREE NITRILE EXAM GLOVES CORNFLOWER BLUE BRAND RS BLUE3500 CTN
2020071627520Singapore,Singapore -> Los Angeles, CaliforniaPF NITRILE GLOVE2147 CTN
2020063025430Port Swettenham,Malaysia -> New York/Newark Area, Newark, New JerseyPF NITRILE GLOVE2186 CTN
2020060110836Port Swettenham,Malaysia -> New York/Newark Area, Newark, New JerseyPF NITRILE GLOVE2482 CTN

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