Omnigrace, Ltd.
Country not established
- Devices
- 8
What Omnigrace, Ltd. makes
Omnigrace, Ltd. manufactures single-use examination gloves in nitrile and latex formulations, including powdered and powder-free variants. The portfolio includes polymer-coated gloves, some with reduced protein content, and gloves available in colors such as blue, green, and turquoise. These products are designed for patient and medical professional use during examinations and procedures.
The company’s devices are classified under Class I under FDA regulations and are listed via 510(k) clearance. The manufacturer is based in the United States, with its products registered in the FDA’s regulatory database.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Omni F.T. Latex Examination Glove, Powdered Ref K973134
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Omnigrace Latex Examination Glove, Powder-Free; Polymer Coated With Protein Claim (50 Micrograms Or Less) Ref K993419
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Omnigrace, Ltd. have in the registry?
The registry currently lists 8 devices for Omnigrace, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Omnigrace, Ltd.'s devices?
Among its 8 most recently registered devices, Omnigrace, Ltd. has devices listed in FDA 510(k) (8 devices).
What risk classes do Omnigrace, Ltd.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for Omnigrace, Ltd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Omnigrace, Ltd. in the registry?
The most recently registered devices listed for Omnigrace, Ltd. include OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED, BLUE, OMNI GRACE NITRILE, BLUE, EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED, PATIENT EXAMINATION GLOVES, NITRILE POWDER FREE, TURQUOISE, NON-STERILE. and PATIENT EXAMINATION GLOVE, NITRILE, POWDERED, TURQUOISE, NON-STERILE.