Data / Medical devices / Panama / Premium Brands Group, S.A
Premium Brands Group, S.A: FDA-registered device maker in Colon, Panama, Panama, 1 510(k) clearance
Premium Brands Group, S.A is registered with the FDA (registration 3009429841) in Colon, Panama, Panama. It lists 7 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 11, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009429841
- Address
- Calle 6ta. Avenida 5ta. Zona Libre de Colon, Panama, Colon, Panama, Panama, 0301-174
- Owner or operator
- Premium Brands Group, S.A (10055796)
- Roles
- Exporter to the US
- First device listed
- September 16, 2025
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cannula, Nasal, Oxygen | CAT | 1 | Exporter to the US | accessdata.fda.gov |
| Dressing, Wound, Hydrophilic | NAC | 1 | Exporter to the US | accessdata.fda.gov |
| Fentanyl And Other Opioid Protection Glove | QDO | 1 | Exporter to the US | accessdata.fda.gov |
| Laryngoscope, Rigid | CCW | 1 | Exporter to the US | accessdata.fda.gov |
| Mask, Oxygen | BYG | 1 | Exporter to the US | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Exporter to the US | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Exporter to the US | 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 |
|---|---|---|---|---|---|---|
| October 11, 2020 | K200633 | Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove | LZC | Substantially Equivalent | 0 & M Halyard, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Cannula, Nasal, Oxygen
- All makers of Dressing, Wound, Hydrophilic
- All makers of Mask, Oxygen
- All makers of Polymer Patient Examination Glove
- All makers of Fentanyl And Other Opioid Protection Glove
- All makers of Medical Glove, Specialty
Updated October 11, 2020. 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.