Omnigrace , Ltd.: FDA clearances and approvals
Omnigrace , Ltd. has 8 FDA 510(k) clearances (first 1997, latest 2000), across 2 product codes in 1 review panel. Median 510(k) review time: 55 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LZA | Polymer Patient Examination Glove | 6 | 6 |
| LYY | Latex Patient Examination Glove | 2 | 2 |
Review panels
- General Hospital (8)
Most recent Omnigrace , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K994246 | OMNI GRACE NITRILE, BLUE, EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED | LZA | 2000-01-31 | 46 |
| K993419 | OMNIGRACE LATEX EXAMINATION GLOVE, POWDER-FREE; POLYMER COATED WITH PROTEIN CLAIM (50 MICROGRAMS OR LESS) | LYY | 1999-11-19 | 38 |
| K993050 | OMNI GRACE NITRILE, GREEN, EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED | LZA | 1999-11-09 | 60 |
| K991846 | PATIENT EXAMINATION GLOVE, NITRILE, POWDERED, TURQUOISE, NON-STERILE | LZA | 1999-08-05 | 69 |
| K991845 | PATIENT EXAMINATION GLOVES, NITRILE POWDER FREE, TURQUOISE,NON-STERILE. | LZA | 1999-08-05 | 69 |
| K983730 | OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE, BLUE | LZA | 1998-12-11 | 50 |
| K983725 | OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED, BLUE | LZA | 1998-12-07 | 46 |
| K973134 | OMNI F.T. LATEX EXAMINATION GLOVE, POWDERED | LYY | 1997-11-06 | 77 |
Recalls
openFDA lists no recalls under a recalling firm named Omnigrace , Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Omnigrace , Ltd. have?
Omnigrace , Ltd. has 8 FDA 510(k) clearances (first 1997, latest 2000), across 2 product codes in 1 review panel.
How long does FDA take to clear Omnigrace , Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Omnigrace , Ltd.'s cleared 510(k)s is 55 days.
What devices does Omnigrace , Ltd. make?
Its most frequent FDA product codes are LZA (Polymer Patient Examination Glove, 6); LYY (Latex Patient Examination Glove, 2).
Has Omnigrace , Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Omnigrace , Ltd. Related entities may recall under other names.
Next steps
- See all 8 Omnigrace , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LZA, Omnigrace , Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.