Medtexx Manufacturing Sdn Bhd

FDA Filings

This page includes the latest FDA filings for Medtexx 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 Number: 3006723110
• FEI Number: 3006723110
• Name: MEDTEXX MANUFACTURING SDN. BHD.
• Owner & Operator: MEDTEXX MANUFACTURING SDN. BHD.
• Contact Address: PT 4004, Jalan Perusahaan 3, Kamunting Industrial Estate; Kamunting, Taiping MY-08 Perak 34600 MY
• US Agent:
  • Jay Mansour
  • Mansour Consulting LLC
  • 678 9088180
  • 678 6233765
  • jay@mansourconsulting.com
• Importing Logistics Registration:
  • Importer: Dynarex Corp. (NY)
  • Address: 8-10 Glenshaw Road ; Orangeburg, NY 10962 UNITED STATES
• Importing Logistics Registration:
  • Importer: Preventive Care Inc.
  • Address: 15125 Boulder Trail ; Rosemount, MN 55068 UNITED STATES
  • Importer Type: Agent
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: PT4004, JALAN PERUSAHAAN 3 ; KAMUNTING, TAIPING Perak, 34600 MY
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMN K183441 | LZC MEDTEXX MANUFACTURING SDN. BHD.	SemperSure Green Nitrile Examination Gloves (SUNG201-SUNG205)	2019-10-20
PMN K183441 | LZC MEDTEXX MANUFACTURING SDN. BHD.	Powder-Free Nitrile Patient Examination Glove, Green Colored, Non-Sterile, Low Dermatitis Potential, And Tested For Use With Chemotherapy Drugs	2019-10-20
PMN K183441 | LZA MEDTEXX MANUFACTURING SDN. BHD.	SemperSure Green Nitrile Examination Gloves (SUNG201-SUNG205)	2019-10-20
PMN K183441 | LZA MEDTEXX MANUFACTURING SDN. BHD.	Powder-Free Nitrile Patient Examination Glove, Green Colored, Non-Sterile, Low Dermatitis Potential, And Tested For Use With Chemotherapy Drugs	2019-10-20
PMN K171378 | LZC MEDTEXX MANUFACTURING SDN. BHD.	Starmed Ultra Nitrile	2017-11-19
PMN K171378 | LZC MEDTEXX MANUFACTURING SDN. BHD.	StarMed Ultra Fresen	2017-11-19
PMN K171378 | LZA MEDTEXX MANUFACTURING SDN. BHD.	Starmed Ultra Nitrile	2017-11-19
PMN K171378 | LZA MEDTEXX MANUFACTURING SDN. BHD.	StarMed Ultra Fresen	2017-11-19
PMN K102189 | LZC MEDTEXX MANUFACTURING SDN. BHD.	Patient examination glove, specialty	2017-01-05
PMN K022548 | LZA MEDTEXX MANUFACTURING SDN. BHD.	Polymer patient examination glove	2017-01-05
PMN K013560 | KGO MEDTEXX MANUFACTURING SDN. BHD.	Surgeon's gloves	2017-01-05
PMN K012819 | KGO MEDTEXX MANUFACTURING SDN. BHD.	Surgeon's gloves	2017-01-05
PMN K011749 | LYY MEDTEXX MANUFACTURING SDN. BHD.	Latex patient examination glove	2017-01-05
PMN K992162 | LZC MEDTEXX MANUFACTURING SDN. BHD.	Patient examination glove, specialty	2017-01-04
PMN K891223 | LYY MEDTEXX MANUFACTURING SDN. BHD.	Latex patient examination glove	2017-01-04
PMN K110921 | LZA MEDTEXX MANUFACTURING SDN. BHD.	Polymer patient examination glove	2017-01-04
PMN K081260 | LZA MEDTEXX MANUFACTURING SDN. BHD.	Polymer patient examination glove	2017-01-04
PMN K081089 | LZC MEDTEXX MANUFACTURING SDN. BHD.	Patient examination glove, specialty	2017-01-04
PMN K032444 | LZC MEDTEXX MANUFACTURING SDN. BHD.	Patient examination glove, specialty	2017-01-04
PMN K022765 | LZA MEDTEXX MANUFACTURING SDN. BHD.	Polymer patient examination glove	2017-01-04
PMN K014087 | LYY MEDTEXX MANUFACTURING SDN. BHD.	Latex patient examination glove	2017-01-04
PMN K120963 | LYY MEDTEXX MANUFACTURING SDN. BHD.	Powder Free Natural Rubber Latex Examination Gloves	2012-07-25
PMN K120963 MEDTEXX MANUFACTURING SDN. BHD.	POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES	2012-06-29
PMN K034052 | LZA MEDTEXX MANUFACTURING SDN. BHD.	Black Colour Powder-Free Nitrile Rubber Examination Glove	2011-06-22
PMN K981767 | LYY MEDTEXX MANUFACTURING SDN. BHD.	Qtexx Powder-Free Latex Examination Gloves with 50	2011-04-28
PMN K981767 | LYY MEDTEXX MANUFACTURING SDN. BHD.	Per Gram	2011-04-28
PMN K981767 | LYY MEDTEXX MANUFACTURING SDN. BHD.	Micrograms or Less of Total Water Extractable Protein	2011-04-28
PMN K071740 MEDTEXX MANUFACTURING SDN. BHD.	CHLORINATED POWDER FREE NITRILE LATEX EXAMINATION GLOVES	2007-10-04
PMN K070821 MEDTEXX MANUFACTURING SDN. BHD.	POWDERED NATURAL RUBBER LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) 200 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE	2007-05-10
PMN K070072 MEDTEXX MANUFACTURING SDN. BHD.	NON-CHLORINATED POLYMER COATED POWDER-FREE NATURAL LATEX EXAMINATION GLOVES	2007-03-15