Onetexx Sdn Bhd is one of 78 FDA 510(k) medical device manufacturers from Malaysia in the dataset, ranked by real submission volume.
Onetexx Sdn Bhd - FDA 510(k) Cleared Devices
Recent clearances: Violet Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl In Gastric Acid, Black Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl In Gastric Acid, Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With the Opioid Fentanyl Citrate, Simulated Gastric Acid, and Fentanyl In Gastric Acid
7
Total
7
Cleared
0
Denied
Onetexx Sdn Bhd has 7 FDA 510(k) cleared medical devices. Based in Kamunting, MY.
Last cleared in 2022. Active since 2021. Primary specialty: General Hospital.
Browse the FDA 510(k) cleared devices submitted by Onetexx Sdn Bhd Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Truscott Medsci Associates, LLC and Emergo Global Representation.
FDA 510(k) Regulatory Record - Onetexx Sdn Bhd
7 devices
Cleared
Oct 18, 2022
Violet Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for...
General Hospital
78d
Cleared
Sep 24, 2022
Black Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for...
General Hospital
54d
Cleared
Jul 30, 2022
Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For...
General Hospital
39d
Cleared
Oct 31, 2021
Black Nitrile Powder Free Patient Examination Glove, Non Sterile
General Hospital
247d
Cleared
Jun 28, 2021
Violet Nitrile Powder Free Patient Examination Glove, Non Sterile
General Hospital
122d
Cleared
Jun 28, 2021
White Nitrile Powder Free Patient Examination Glove, Non Sterile
General Hospital
105d
Cleared
May 07, 2021
Blue Nitrile Powder Free Patient Examination Glove, Non Sterile
General Hospital
88d