Data / Medical devices / Malaysia / Onetexx Sdn Bhd
Onetexx Sdn Bhd: FDA-registered device maker in Kamunting Perak, Malaysia, 3 510(k) clearances
Onetexx Sdn Bhd is registered with the FDA (registration 3019252794) in Kamunting Perak, Malaysia. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated October 18, 2022. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3019252794
- Address
- No: 73 - 86, Jalan Logam 5, Perindustrian Kamunting 3, Kamunting Raya Industrial Park, Kamunting Perak, Malaysia, 34600
- Owner or operator
- Onetexx Sdn Bhd (10081868)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- May 21, 2021
- Registered through
- 2026
- Brand names listed
- Black Nitrile Powder Free Patient Examination Glove, Non Sterile, Blue Nitrile Powder Free Patient Examination Glove, Non Sterile, Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With the Opioid Fentanyl Citrate, Simula, Kenaflexx Nitrile Examination Gloves Powder Free Black, LYDUS, Nitrile Powder Free Dark Blue Examination Gloves (Tested for use with Chemotherapy Drugs), Violet Nitrile Powder Free Patient Examination Glove, Non-Sterile, Violet Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy Drugs, the Opioid Fe and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | QDO | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 18, 2022 | 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 Acid | LZA | Substantially Equivalent | Onetexx Sdn Bhd | accessdata.fda.gov |
| June 28, 2021 | K210587 | Violet Nitrile Powder Free Patient Examination Glove, Non Sterile | LZA | Substantially Equivalent | Onetexx Sdn Bhd | accessdata.fda.gov |
| May 7, 2021 | K210366 | Blue Nitrile Powder Free Patient Examination Glove, Non Sterile | LZA | Substantially Equivalent | Onetexx Sdn Bhd | accessdata.fda.gov |
Compare with other makers
- All makers of Polymer Patient Examination Glove
- All makers of Medical Glove, Specialty
- All makers of Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
- All makers of Fentanyl And Other Opioid Protection Glove
Updated October 18, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.