Onetexx Sdn Bhd: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Onetexx Sdn Bhd” (first 2021, latest 2022), across 1 product code in 1 review panel. Median 510(k) review time under this name: 88 days. Since 2017 the median was 88 days, against 112 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2021 | 4 | 114 |
| 2022 | 3 | 54 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Onetexx Sdn Bhd took a median 88 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 112 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LZA | Polymer Patient Examination Glove | 7 | 7 |
Review panels
- General Hospital (7)
Most recent Onetexx Sdn Bhd 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| 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 | 2022-10-18 | 78 |
| 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 | 2022-09-24 | 54 |
| 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 | 2022-07-30 | 39 |
| K210588 | Black Nitrile Powder Free Patient Examination Glove, Non Sterile | LZA | 2021-10-31 | 247 |
| K210775 | White Nitrile Powder Free Patient Examination Glove, Non Sterile | LZA | 2021-06-28 | 105 |
| K210587 | Violet Nitrile Powder Free Patient Examination Glove, Non Sterile | LZA | 2021-06-28 | 122 |
| K210366 | Blue Nitrile Powder Free Patient Examination Glove, Non Sterile | LZA | 2021-05-07 | 88 |
Recalls
openFDA lists no recalls under a recalling firm named Onetexx Sdn Bhd.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Onetexx Sdn Bhd?
FDA lists 7 510(k) clearances under the applicant name “Onetexx Sdn Bhd” (first 2021, latest 2022), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Onetexx Sdn Bhd?
The median time from FDA receipt to decision across 510(k)s cleared under the name Onetexx Sdn Bhd is 88 days. Since 2017: 88 days, versus 112 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Onetexx Sdn Bhd?
The most frequent FDA product codes under this applicant name are LZA (Polymer Patient Examination Glove, 7).
Next steps
- See all 7 Onetexx Sdn Bhd clearances with predicates and recalls
- Run predicate analysis for product code LZA, Onetexx Sdn Bhd's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.