Onetexx Sdn Bhd
Kamunting Perak, MY
ONETEXX SDN BHD appears in FDA device records in Kamunting Perak, MY. FDA records list 7 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for Onetexx Sdn Bhd between 2021 and 2022. The busiest year on record is 2021, with 4. The most recent is 2022, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2021 | 4 |
| 2022 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| 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 | |
| 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 Acid | LZA | Substantially Equivalent | |
| 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 Acid | LZA | Substantially Equivalent | |
| K210588 | Black Nitrile Powder Free Patient Examination Glove, Non Sterile | LZA | Substantially Equivalent | |
| K210775 | White Nitrile Powder Free Patient Examination Glove, Non Sterile | LZA | Substantially Equivalent | |
| K210587 | Violet Nitrile Powder Free Patient Examination Glove, Non Sterile | LZA | Substantially Equivalent | |
| K210366 | Blue Nitrile Powder Free Patient Examination Glove, Non Sterile | LZA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3019252794 | 3019252794 | ONETEXX SDN BHD | No: 73 - 86, Jalan Logam 5, Perindustrian Kamunting 3,, Kamunting Perak 34600 MY | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain