Omnigrace (Thailand) , Ltd.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Omnigrace (Thailand) , Ltd.” (first 1998, latest 2001), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 62 days. 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 |
|---|---|---|
| 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 | 5 | 5 |
| KGO | Surgeon'S Gloves | 1 | 1 |
Review panels
- General Hospital (12)
Most recent Omnigrace (Thailand) , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K012402 | OMNI GRACE LATEX EXAMINATION GLOVE, POWDER FREE, POLYMER COATED WITH PROTEIN CLAIM | LYY | 2001-10-12 | 77 |
| K002922 | OMNI GRACE LATEX EXAMINATION GLOVE, POWDERED, WITH PROTEIN CLAIM (200 MICROGRAMS OR LESS) | LYY | 2000-10-16 | 27 |
| K993479 | OMNI GRACE LATEX EXAMINATION GLOVE, POWDERED, WITH PROTEIN CLAIM (100 MICROGRAMS OR LESS) | LYY | 1999-11-19 | 36 |
| K990698 | OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED PURPLE | LZA | 1999-05-13 | 71 |
| K990696 | OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE,WHITE | LZA | 1999-05-13 | 71 |
| K990701 | OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE, PURPLE | LZA | 1999-05-05 | 63 |
| K990702 | OMNI GRACE LATEX EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED WITH PROTEIN CLAIM | LYY | 1999-05-04 | 62 |
| K990695 | OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED WHITE | LZA | 1999-05-04 | 62 |
| K982716 | OMNIGRACE LATEX EXAMINATION GLOVE, POWDER-FREE, WITH PROTEIN CLAIM | LYY | 1998-11-30 | 118 |
| K982613 | OMNI PRO LATEX SURGICAL GLOVE, POWDERED | KGO | 1998-09-02 | 37 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Omnigrace (Thailand) , Ltd..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Omnigrace , Ltd. (8 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Omnigrace (Thailand) , Ltd.?
FDA lists 12 510(k) clearances under the applicant name “Omnigrace (Thailand) , Ltd.” (first 1998, latest 2001), across 3 product codes 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 Omnigrace (Thailand) , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Omnigrace (Thailand) , Ltd. is 62 days.
Which FDA product codes appear under Omnigrace (Thailand) , Ltd.?
The most frequent FDA product codes under this applicant name are LZA (Polymer Patient Examination Glove, 6); LYY (Latex Patient Examination Glove, 5); KGO (Surgeon'S Gloves, 1).
Next steps
- See all 12 Omnigrace (Thailand) , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LZA, Omnigrace (Thailand) , Ltd.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.