Data / Medical devices / United States / PremiumEStore LLC, d.b.a. Premium-PPE
PremiumEStore LLC, d.b.a. Premium-PPE: FDA-registered device maker in Virginia Beach, VA, United States, 2 510(k) clearances
PremiumEStore LLC, d.b.a. Premium-PPE is registered with the FDA (registration 3016753714) in Virginia Beach, VA, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated June 15, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016753714
- Address
- 2601 Reliance Drive #102, Virginia Beach, VA, United States, 23452
- Owner or operator
- Premium-PPE (10071329)
- Roles
- Manufacturer
- First device listed
- July 14, 2021
- Registered through
- 2026
- Brand names listed
- AirMax Procedure Mask, Amerishield Surgical Mask
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Mask, Surgical | FXX | 2 | Manufacturer | 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 15, 2021 | K211520 | Amerishield Surgical Mask | FXX | Substantially Equivalent | Premiumestore, LLC | accessdata.fda.gov |
| May 25, 2021 | K211275 | AirMax Procedure Mask | FXX | Substantially Equivalent | Premiumestore, LLC | accessdata.fda.gov |
Compare with other makers
Updated June 15, 2021. 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.