Data / Medical devices / United States / Vital Edge Instruments LLC
Vital Edge Instruments LLC: FDA-registered device maker in Leesburg, VA, United States, 1 510(k) clearance
Vital Edge Instruments LLC is registered with the FDA (registration 3042765418) in Leesburg, VA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated February 28, 2013. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3042765418
- Address
- 1762 Moultrie Ter Ne, Leesburg, VA, United States, 20176
- Owner or operator
- Vital Edge Instruments LLC (10094542)
- Roles
- Repackager or relabeler, Specification developer
- First device listed
- December 6, 2025
- Registered through
- 2026
- Brand names listed
- Vital Edge Intrsuments llc - L4_BLU_NIT_MED_GLOVE
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Polymer Patient Examination Glove | LZA | 1 | Repackager or relabeler, Specification developer | 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 |
|---|---|---|---|---|---|---|
| February 28, 2013 | K123869 | POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES | LZA | Substantially Equivalent | Dehai (Shandong) Medical Gloves, Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated February 28, 2013. 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.