Data / Medical devices / United States / Gel-X LLC
Gel-X LLC: FDA-registered device maker in Wilmington, DE, United States, 2 510(k) clearances
Gel-X LLC is registered with the FDA (registration 3015729128) in Wilmington, DE, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 24, 2013. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3015729128
- Address
- 251 Little Falls Dr, Wilmington, DE, United States, 19808
- Owner or operator
- GEL-X LLC (10060658)
- Roles
- Manufacturer, Specification developer
- First device listed
- July 18, 2019
- Registered through
- 2026
- Brand names listed
- ALLOGEL
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Latex Patient Examination Glove | LYY | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Manufacturer, 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 |
|---|---|---|---|---|---|---|
| July 24, 2013 | K130667 | POWDERFREE LATEX EXAMINATION GLOVES COATED WITH ALLOGEL | LYY | Substantially Equivalent | Preventive Care, Inc. | accessdata.fda.gov |
| May 13, 2011 | K110102 | POWDERFREE NITRILE EXAMINATION GLOVES COATED WITH ALLOGEL,COLORS BLUE,MAGNETA,COPPER AND WITHOUT ALLOGEL,COLORS BLUE,MAG | LZA | Substantially Equivalent | Preventive Care, Inc. | accessdata.fda.gov |
Compare with other makers
Updated July 24, 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.