Data / Medical devices / United States / Ug Healthcare (usa), Inc.
Ug Healthcare (usa), Inc.: FDA-registered device maker in Costa Mesa, CA, United States, 2 510(k) clearances
Ug Healthcare (usa), Inc. is registered with the FDA (registration 2087418) in Costa Mesa, CA, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 21, 2012. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 2087418
- FEI number
- 3001133325
- Address
- 1565 Sunflower Avenue, Costa Mesa, CA, United States, 92626
- Owner or operator
- UG HEALTHCARE (USA), INC. (9051933)
- Roles
- Specification developer
- First device listed
- October 19, 2015
- Registered through
- 2027
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Latex Patient Examination Glove | LYY | 1 | Specification developer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | 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 |
|---|---|---|---|---|---|---|
| March 21, 2012 | K112012 | NON-STERILE, POWDER-FREE BLUE, NITRILE EXAMINATION GLOVES | LZA | Substantially Equivalent | Ug Healthcare (Usa), Inc. | accessdata.fda.gov |
| November 30, 2006 | K062688 | POWDER-FREE BLACK LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM | LYY | Substantially Equivalent | Ug Healthcare (Usa), Inc. | accessdata.fda.gov |
Compare with other makers
Updated March 21, 2012. 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.