Data / Medical devices / United States / Infab, LLC.
Infab, LLC.: FDA-registered device maker in Camarillo, CA, United States, 4 510(k) clearances
Infab, LLC. is registered with the FDA (registration 2024351) in Camarillo, CA, United States. It lists 9 device types. The FDA files 4 510(k) clearances under its listings, the newest dated March 21, 2003. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2024351
- Address
- 1040 Avenida Acaso, Camarillo, CA, United States, 93012
- Owner or operator
- INFAB, LLC (2024351)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- May 20, 1998
- Registered through
- 2026
- Brand names listed
- Classic Aprons, INFAB Mobile Radiation Protection Barriers and Shields, Isolation Gown, Kerr Total Care, Leaded Eyewear, Lightning Aprons, POWDER-FREE RADIATION ATTENUATING NEOPRENE SURGICAL GLOVE, Patient Transfer Device and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Apron, Leaded | EAJ | 1 | Manufacturer | accessdata.fda.gov |
| Apron, Protective | IWO | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Device, Transfer, Patient, Manual | FMR | 1 | Manufacturer | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Manufacturer | accessdata.fda.gov |
| Radiographic Protective Glove | IWP | 1 | Manufacturer | accessdata.fda.gov |
| Screen, Leaded, Operator Radiation Protector | EAK | 1 | Manufacturer | accessdata.fda.gov |
| Shield, Eye, Radiological | IWS | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Shield, Protective, Personnel | KPY | 1 | Manufacturer | accessdata.fda.gov |
| Surgeon'S Gloves | KGO | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 21, 2003 | K022873 | POWDER-FREE RADIATION ATTENUATING NEOPRENE SURGICAL GLOVE (BLACK) | KGO | Substantially Equivalent | International Biomedical, Inc. | accessdata.fda.gov |
| May 1, 1990 | K900972 | RADIATION PROTECTION GLOVES | IWP | Substantially Equivalent | Infab Corp. | accessdata.fda.gov |
| May 1, 1990 | K900970 | RADIATION PROTECTION GLASSES | KPY | Substantially Equivalent | Infab Corp. | accessdata.fda.gov |
| December 14, 1989 | K896289 | RADIATION PROTECTION APRON | KPY | Substantially Equivalent | Infab Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Surgeon'S Gloves
- All makers of Shield, Eye, Radiological
- All makers of Radiographic Protective Glove
- All makers of Shield, Protective, Personnel
- All makers of Apron, Leaded
- All makers of Apron, Protective
Updated March 21, 2003. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.