Omnigrace (Thailand), Ltd.
North Canton, OH, US
Omnigrace (Thailand) , Ltd. appears in FDA device records in North Canton, OH. FDA records list 12 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 12
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 12 510(k) clearances for Omnigrace (Thailand), Ltd. between 1998 and 2001. The busiest year on record is 1999, with 6. The most recent is 2001, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1998 | 4 |
| 1999 | 6 |
| 2000 | 1 |
| 2001 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K012402 | OMNI GRACE LATEX EXAMINATION GLOVE, POWDER FREE, POLYMER COATED WITH PROTEIN CLAIM | LYY | Substantially Equivalent | |
| K002922 | OMNI GRACE LATEX EXAMINATION GLOVE, POWDERED, WITH PROTEIN CLAIM (200 MICROGRAMS OR LESS) | LYY | Substantially Equivalent | |
| K993479 | OMNI GRACE LATEX EXAMINATION GLOVE, POWDERED, WITH PROTEIN CLAIM (100 MICROGRAMS OR LESS) | LYY | Substantially Equivalent | |
| K990698 | OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED PURPLE | LZA | Substantially Equivalent | |
| K990696 | OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE,WHITE | LZA | Substantially Equivalent | |
| K990701 | OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE, PURPLE | LZA | Substantially Equivalent | |
| K990702 | OMNI GRACE LATEX EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED WITH PROTEIN CLAIM | LYY | Substantially Equivalent | |
| K990695 | OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED WHITE | LZA | Substantially Equivalent | |
| K982716 | OMNIGRACE LATEX EXAMINATION GLOVE, POWDER-FREE, WITH PROTEIN CLAIM | LYY | Substantially Equivalent | |
| K982613 | OMNI PRO LATEX SURGICAL GLOVE, POWDERED | KGO | Substantially Equivalent | |
| K980421 | OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED | LZA | Substantially Equivalent | |
| K980419 | OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE | LZA | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain