Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Onetexx Sdn Bhd

FDA 510(k) & PMA Approved Devices — 7 products

Total Devices7
Categories1
Latest FDA decision2022-10-18
TypeNumberDevice NameCodeDateActions
510(k) K222298 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 AcidLZA2022-10-18 View
510(k) K222294 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 AcidLZA2022-09-24 View
510(k) K221773 Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With the Opioid Fentanyl Citrate, Simulated Gastric Acid, and Fentanyl In Gastric AcidLZA2022-07-30 View
510(k) K210588 Black Nitrile Powder Free Patient Examination Glove, Non SterileLZA2021-10-31 View
510(k) K210775 White Nitrile Powder Free Patient Examination Glove, Non SterileLZA2021-06-28 View
510(k) K210587 Violet Nitrile Powder Free Patient Examination Glove, Non SterileLZA2021-06-28 View
510(k) K210366 Blue Nitrile Powder Free Patient Examination Glove, Non SterileLZA2021-05-07 View
↑