Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Omnigrace , Ltd. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
60 daysmedian FDA review time
77 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K994246 | OMNI GRACE NITRILE, BLUE, EXAMINATION GLOVE, POWDER-FREE, PO | Omnigrace , Ltd. | 2000-01-31 | 46 | 0 |
| K993419 | OMNIGRACE LATEX EXAMINATION GLOVE, POWDER-FREE; POLYMER COAT | Omnigrace , Ltd. | 1999-11-19 | 38 | 0 |
| K993050 | OMNI GRACE NITRILE, GREEN, EXAMINATION GLOVE, POWDER-FREE, P | Omnigrace , Ltd. | 1999-11-09 | 60 | 0 |
| K991845 | PATIENT EXAMINATION GLOVES, NITRILE POWDER FREE, TURQUOISE,N | Omnigrace , Ltd. | 1999-08-05 | 69 | 0 |
| K991846 | PATIENT EXAMINATION GLOVE, NITRILE, POWDERED, TURQUOISE, NON | Omnigrace , Ltd. | 1999-08-05 | 69 | 0 |
| K983730 | OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE, BLUE | Omnigrace , Ltd. | 1998-12-11 | 50 | 0 |
| K983725 | OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED, BLUE | Omnigrace , Ltd. | 1998-12-07 | 46 | 0 |
| K973134 | OMNI F.T. LATEX EXAMINATION GLOVE, POWDERED | Omnigrace , Ltd. | 1997-11-06 | 77 | 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