Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
One Glove Industrial Sdn Bhd · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K220431 | Blue Nitrile Powder-Free Patient Examination Glove, Non-Ster | One Glove Industrial Sdn Bhd | 2022-06-17 | 122 | 0 |
| K220429 | Violet Nitrile Powder-Free Patient Examination Glove, Non St | One Glove Industrial Sdn Bhd | 2022-05-13 | 87 | 0 |
| K220427 | White Nitrile Powder-Free Patient Examination Glove, Non Ste | One Glove Industrial Sdn Bhd | 2022-05-10 | 84 | 0 |
| K220428 | Black Nitrile Powder-Free Patient Examination Glove, Non-Ste | One Glove Industrial Sdn Bhd | 2022-05-10 | 84 | 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