Data / Medical devices / United States / Armbrust Inc.
Armbrust Inc.: FDA-registered device maker in Elgin, TX, United States, 5 510(k) clearances
Armbrust Inc. is registered with the FDA (registration 3016866909) in Elgin, TX, United States. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated November 7, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016866909
- Address
- 1011 Old McDade Rd, Elgin, TX, United States, 78621
- Owner or operator
- Armbrust Inc. (10073694)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler
- First device listed
- September 2, 2022
- Registered through
- 2026
- Brand names listed
- American Made Surgical Mask, Blue Powder-Free Nitrile Exam Gloves, GLOVE-ARMBRUST-3.2MIL-BLUE, KN Style Flat Fold Surgical Mask, Medical Face Mask
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Mask, Surgical | FXX | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Repackager or relabeler | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 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 |
|---|---|---|---|---|---|---|
| November 7, 2022 | K222898 | SafeSource Direct Blue Powder-Free Nitrile Exam Gloves | LZA | Substantially Equivalent | Safesource Direct, LLC | accessdata.fda.gov |
| January 26, 2022 | K210101 | American-Made Surgical Mask | FXX | Substantially Equivalent | Armbrust, Inc. | accessdata.fda.gov |
| December 2, 2021 | K212740 | Puravita Medical Fold Flat Surgical Mask | FXX | Substantially Equivalent | Puravita M, LLC | accessdata.fda.gov |
| June 15, 2021 | K211520 | Amerishield Surgical Mask | FXX | Substantially Equivalent | Premiumestore, LLC | accessdata.fda.gov |
| March 16, 2005 | K050530 | POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES (BLUE,WHITE,VIOLET, PINK,GREEN) | LZA | Substantially Equivalent | Spi Gloves Sdn. Bhd. | accessdata.fda.gov |
Compare with other makers
- All makers of Polymer Patient Examination Glove
- All makers of Mask, Surgical
- All makers of Medical Glove, Specialty
Updated November 7, 2022. 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.