FDA 510(k) Applications Submitted by ONETEXX SDN BHD
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K210366 |
02/08/2021 |
Blue Nitrile Powder Free Patient Examination Glove, Non Sterile |
Onetexx SDN BHD |
| K210587 |
02/26/2021 |
Violet Nitrile Powder Free Patient Examination Glove, Non Sterile |
Onetexx SDN BHD |
| K210588 |
02/26/2021 |
Black Nitrile Powder Free Patient Examination Glove, Non Sterile |
Onetexx SDN BHD |
| K210775 |
03/15/2021 |
White Nitrile Powder Free Patient Examination Glove, Non Sterile |
Onetexx SDN BHD |
| K221773 |
06/21/2022 |
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 |
ONETEXX SDN BHD |
| K222294 |
08/01/2022 |
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 |
Onetexx SDN BHD |
| K222298 |
08/01/2022 |
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 |
Onetexx SDN BHD |
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