Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Onetexx Sdn Bhd · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
247 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K222298 | Violet Nitrile Powder Free Patient Examination Glove, Non-St | Onetexx Sdn Bhd | 2022-10-18 | 78 | 0 |
| K222294 | Black Nitrile Powder Free Patient Examination Glove, Non-Ste | Onetexx Sdn Bhd | 2022-09-24 | 54 | 0 |
| K221773 | Blue Nitrile Powder Free Patient Examination Glove, Non-Ster | Onetexx Sdn Bhd | 2022-07-30 | 39 | 0 |
| K210588 | Black Nitrile Powder Free Patient Examination Glove, Non Ste | Onetexx Sdn Bhd | 2021-10-31 | 247 | 0 |
| K210587 | Violet Nitrile Powder Free Patient Examination Glove, Non St | Onetexx Sdn Bhd | 2021-06-28 | 122 | 0 |
| K210775 | White Nitrile Powder Free Patient Examination Glove, Non Ste | Onetexx Sdn Bhd | 2021-06-28 | 105 | 0 |
| K210366 | Blue Nitrile Powder Free Patient Examination Glove, Non Ster | Onetexx Sdn Bhd | 2021-05-07 | 88 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda