Latexx Manufacturing Sdn Bhd

FDA Filings

This page includes the latest FDA filings for Latexx Manufacturing 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 Number8041003
FEI Number3009157666
NameJay Mansour
Owner & OperatorLatexx Manufacturing Sdn. Bhd.
Contact AddressPT 32571, JALAN PERUSAHAAN 3, KAMUNTING INDUSTRIAL ESTATE
TAIPING MY-08 Perak 34600 MY
US Agent
Importing Logistics Registration
ImporterSpring-Fill Industries, Inc
Address2855 Shermer Road
Northbrook, IL 60062 UNITED STATES
Email Addressskolpas@spring-fill.com
Phone1 847 2051875
FAX1 847 2051710
Importer TypeAGENT
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address845 Aronson Lake Court
Roswell, GA 30075 US
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
Jay Mansour [Latexx Manufacturing Sdn. Bhd.]
SemperSure Green Nitrile Examination Gloves (SUNG201-SUNG205)2019-10-20
Jay Mansour [Latexx Manufacturing Sdn. Bhd.]
Powder-Free Nitrile Patient Examination Glove, Green Colored, Non-Sterile, Low Dermatitis Potential, And Tested For Use2019-10-20
Jay Mansour [Latexx Manufacturing Sdn. Bhd.]
SemperSure Green Nitrile Examination Gloves (SUNG201-SUNG205)2019-10-20
Jay Mansour [Latexx Manufacturing Sdn. Bhd.]
Powder-Free Nitrile Patient Examination Glove, Green Colored, Non-Sterile, Low Dermatitis Potential, And Tested For Use2019-10-20
Jay Mansour [Latexx Manufacturing Sdn. Bhd.]
Starmed Ultra Nitrile2017-11-19
Jay Mansour [Latexx Manufacturing Sdn. Bhd.]
Starmed Ultra Fresen2017-11-19
Jay Mansour [Latexx Manufacturing Sdn. Bhd.]
Starmed Ultra Nitrile2017-11-19
Jay Mansour [Latexx Manufacturing Sdn. Bhd.]
Starmed Ultra Fresen2017-11-19
Jay Mansour [Latexx Manufacturing Sdn. Bhd.]
Polymer patient examination glove2017-01-05
Jay Mansour [Latexx Manufacturing Sdn. Bhd.]
Patient examination glove, specialty2017-01-05
Jay Mansour [Latexx Manufacturing Sdn. Bhd.]
Polymer patient examination glove2017-01-05
Jay Mansour [Latexx Manufacturing Sdn. Bhd.]
Latex patient examination glove2017-01-05
Jay Mansour [Latexx Manufacturing Sdn. Bhd.]
Latex patient examination glove2017-01-05
Jay Mansour [Latexx Manufacturing Sdn. Bhd.]
Polymer patient examination glove2017-01-05
Jay Mansour [Latexx Manufacturing Sdn. Bhd.]
Surgeon's gloves2017-01-05
Jay Mansour [Latexx Manufacturing Sdn. Bhd.]
Surgeon's gloves2017-01-05
Jay Mansour [Latexx Manufacturing Sdn. Bhd.]
Latex Examination Powder-Free Gloves2015-09-16
Jay Mansour [Latexx Manufacturing Sdn. Bhd.]
Powdered Latex Examination Gloves2015-09-11
Jay Mansour [Latexx Manufacturing Sdn. Bhd.]
Nitrile Cornflower Blue Powder-Free Exam Tested for Use with Chemotherapy Drugs (Non-Sterile)2014-09-10
Jay Mansour [Latexx Manufacturing Sdn. Bhd.]
Nitrile Powdered-Free Examination Glove with Lotion Coating And use for Chemotherapy2014-09-10
Jay Mansour [Latexx Manufacturing Sdn. Bhd.]
Nitrile Examination Powder-Free Gloves2012-04-10
LATEXX MANUFACTURING SDN.BHD.
POWDER FREE NITRLE EXAMINATION GLOVES WITH CHEMOTHERAPY LABELING CLAIM2012-03-14
Jay Mansour [Latexx Manufacturing Sdn. Bhd.]
Powder-Free Blue Nitrile Examination Gloves with Tested For Use with Chemotherapy Drugs labeling Claim2011-02-09
LATEXX MANUFACTURING SDN.BHD.
NON-CHLORINATED, POLYMER COATED POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES AND PROTEIN LABELING CLAIM OF2010-08-26
Jay Mansour [Latexx Manufacturing Sdn. Bhd.]
Proflex* Powder Free Nitrile Examiantion Gloves2007-12-11
Jay Mansour [Latexx Manufacturing Sdn. Bhd.]
Medtexx Blue Colour Powder-Free Nitrile Rubber Examination Gloves2007-12-11
Jay Mansour [Latexx Manufacturing Sdn. Bhd.]
Water Extractable Protein Per Gram2007-12-07
Jay Mansour [Latexx Manufacturing Sdn. Bhd.]
Qtexx Powder-Free Latex Examination Gloves with 50 Micrograms or Less of Total2007-12-07
Jay Mansour [Latexx Manufacturing Sdn. Bhd.]
Patient Examination Gloves (Latex)2007-12-07
Jay Mansour [Latexx Manufacturing Sdn. Bhd.]
Black Colour Powder-Free Nitrile Rubber Examination Gloves2007-12-07
Jay Mansour [Latexx Manufacturing Sdn. Bhd.]
Latexx Manufacturing Non-Chlorinated, Polymer Coated, Powder Free Natural Rubber2007-12-07
Jay Mansour [Latexx Manufacturing Sdn. Bhd.]
Latex Examination Gloves2007-12-07
LATEXX MANUFACTURING SDN.BHD.
BLACK COLOUR POWDER-FREE NITRILE RUBBER EXAMINATION GLOVES2004-03-15
LATEXX MANUFACTURING SDN.BHD.
MEDTEXX BLUE COLOUR POWDER-FREE NITRILE RUBBER EXAMINATION GLOVES2002-08-15
LATEXX MANUFACTURING SDN.BHD.
MEDTEXX GREEN COLOUR POWDERED NITRILE RUBBER EXAMINATION GLOVES2002-08-15
LATEXX MANUFACTURING SDN.BHD.
LATEXX MANUFACTURING NON-CHLORINATED, POLYMER COATED, POWDER-FREE RUBBER LATEX EXAMINATION GLOVE2002-03-04

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
202009173204Pinang,Malaysia -> Tacoma, Washington3,600 CARTONS OF GLOVES3600 CTN
202009097010Pinang,Malaysia -> Tacoma, Washington3,600 CARTONS OF GLOVES3600 CTN
2020090112258Quanzhou,China (Mainland) -> Long Beach, CaliforniaONLINE CHLORINATED NITRILE POWDER FREE VIOL ET BLUE GLOVES ONLINE CHLORINATED NITRILE POWDER FREE VIOLET BLUE GLOVES ONLINE CHLORINATED NITRILE POWDER FREE VIOLET BLUE GLOVES3564 CTN
202008076432Bremerhaven,Federal Republic of Germany -> Boston, MassachusettsRUBBER GLOVES2277 CTN
202007203533Pusan,South Korea -> Long Beach, CaliforniaFINGER TEXTURED ONLINE CHLORINATED NITRILE POWDER FREE VIOLET BLUE GLOVES BRAND SEMPERCARE NITRILE SKIN2 100 CLEAN ON BOARD FREIGHT COLLECT FOB PENANG, MALAYSIA LOADED ON SINAR SABANG V.601S ON 07 JUNE 2020 AT PENANG, MALAYSIA CONNECTING MSC KANOKO V.FA024A AT4570 PCS
202007186558Pusan,South Korea -> Long Beach, CaliforniaFINGER TEXTURED ONLINE CHLORINATED NITRILE POWDER FREE VIOLET BLUE GLOVES BRAND SEMPERCARE NITRILE SKIN2 100 CLEAN ON BOARD FREIGHT COLLECT FOB PENANG, MALAYSIA LOADED ON SINAR SABANG V.601S ON 07 JUNE 2020 AT PENANG, MALAYSIA CONNECTING MSC KANOKO V.FA024A AT4570 PCS
2020071730688Pinang,Malaysia -> Tacoma, Washington1 X 40GP CONTAINER STC: 3,179 CARTONS OF GLOV ES3179 CTN
202007167865Pusan,South Korea -> Long Beach, CaliforniaFINGER TEXTURED ONLINE CHLORINATED NITRILE POWDER FREE VIOLET BLUE GLOVES BRAND SEMPERCARE NITRILE SKIN2 100 CLEAN ON BOARD FREIGHT COLLECT FOB PENANG, MALAYSIA LOADED ON SINAR SABANG V.601S ON 07 JUNE 2020 AT PENANG, MALAYSIA CONNECTING MSC KANOKO V.FA024A AT4570 PCS

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