Data / Medical devices / United States / Clark Core Services, LLC
Clark Core Services, LLC: FDA-registered device maker in Lancaster, PA, United States, 1 510(k) clearance
Clark Core Services, LLC is registered with the FDA (registration 3010895961) in Lancaster, PA, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 31, 2011. 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
- 3010895961
- Address
- 2205 Old Philadelphia Pike, Lancaster, PA, United States, 17602
- Owner or operator
- Clark Core Services, LLC (10049144)
- Roles
- Repackager or relabeler
- First device listed
- March 2, 2017
- Registered through
- 2026
- Brand names listed
- AvaWeigh, Galaxy, Noble gloves
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Polymer Patient Examination Glove | LZA | 1 | Repackager or relabeler | accessdata.fda.gov |
| Scale, Stand-On, Patient | FRI | 1 | Repackager or relabeler | 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 31, 2011 | K103670 | NITRILE EXAMINATION GLOVES POLYMER COATED (WHITE, BLUE, AND BLACK COLOR) | LZA | Substantially Equivalent | Innovative Gloves Co;, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated March 31, 2011. 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.