Data / Medical devices / United States / Ammex Corporation
Ammex Corporation: FDA-registered device maker in Kent, WA, United States, 1 510(k) clearance
Ammex Corporation is registered with the FDA (registration 3023862) in Kent, WA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated December 18, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3023862
- Address
- 1019 W James St, Kent, WA, United States, 98032
- Owner or operator
- Ammex Corporation (10026591)
- Roles
- Manufacturer
- First device listed
- February 22, 2022
- Registered through
- 2026
- Brand names listed
- Powder Free Nitrile Examination Gloves (Black), Powder Free Nitrile Examination Gloves (Blue), Powder Free Nitrile Examination Gloves (Indigo)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Polymer Patient Examination Glove | LZA | 1 | 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 |
|---|---|---|---|---|---|---|
| December 18, 2021 | K211457 | Powder Free Nitrile Examination Gloves (Blue, Black, Indigo) | LZA | Substantially Equivalent | Ammex Corporation | accessdata.fda.gov |
Compare with other makers
Updated December 18, 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.