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Onetexx Sdn Bhd FDA Approvals
0 new drug approvals and 7 device clearances on file. This applicant is not matched to a listed company.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| 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 Acid510(k)Oct 18, 2022General Hospital |
| 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 Acid510(k)Sep 24, 2022General Hospital |
| Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With the Opioid Fentanyl Citrate, Simulated Gastric Acid, and Fentanyl In Gastric Acid510(k)Jul 30, 2022General Hospital |
| Black Nitrile Powder Free Patient Examination Glove, Non Sterile510(k)Oct 31, 2021General Hospital |
| White Nitrile Powder Free Patient Examination Glove, Non Sterile510(k)Jun 28, 2021General Hospital |
| Violet Nitrile Powder Free Patient Examination Glove, Non Sterile510(k)Jun 28, 2021General Hospital |
| Blue Nitrile Powder Free Patient Examination Glove, Non Sterile510(k)May 7, 2021General Hospital |