Data / Medical devices / United States / Dell Corning Corporation
Dell Corning Corporation: FDA-registered device maker in Spartanburg, SC, United States, 1 510(k) clearance
Dell Corning Corporation is registered with the FDA (registration 3004113569) in Spartanburg, SC, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated June 5, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004113569
- Address
- 575 John Dodd Rd, Spartanburg, SC, United States, 29303
- Owner or operator
- Dell Corning Corporation (10082321)
- Roles
- Complaint file establishment
- First device listed
- February 12, 2025
- Registered through
- 2026
- Brand names listed
- APOLLO ADVANTAGE
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Polymer Patient Examination Glove | LZA | 1 | Complaint file establishment | 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 |
|---|---|---|---|---|---|---|
| June 5, 2023 | K230633 | APOLLO ADVANTAGE Nitrile Examination Gloves | LZA | Substantially Equivalent | Dell Corning Corporation | accessdata.fda.gov |
Compare with other makers
Updated June 5, 2023. 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.