Data / Medical devices / United States / SafeSource Direct Glove Plant
SafeSource Direct Glove Plant: FDA-registered device maker in Broussard, LA, United States, 1 510(k) clearance
SafeSource Direct Glove Plant is registered with the FDA (registration 3024999439) in Broussard, LA, United States. It lists 2 device types. The FDA files 1 510(k) clearance 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
- 3024999439
- Address
- 142 Lake Talon Road, Broussard, LA, United States, 70518
- Owner or operator
- SafeSource Direct (10084021)
- Roles
- Manufacturer
- First device listed
- November 10, 2022
- Registered through
- 2026
- Brand names listed
- SafeSource Direct Ameri-Touch Nitrile Exam Gloves, SafeSource Direct Ameri-Tuff Nitrile Gloves
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Medical Glove, Specialty | LZC | 1 | Manufacturer | accessdata.fda.gov |
| 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 |
|---|---|---|---|---|---|---|
| November 7, 2022 | K222898 | SafeSource Direct Blue Powder-Free Nitrile Exam Gloves | LZA | Substantially Equivalent | Safesource Direct, LLC | accessdata.fda.gov |
Compare with other makers
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.