# Safesource Direct, LLC

- Location (FDA's records): Broussard, LA
- FDA decisions: 3 (2022–2025): 3 510(k) clearances
- Product codes: LZA (2), FXX (1)
- 510(k) review time since 2016: median 30 days, against 111 for FDA's reviews in the same codes and years (3 of 3 faster)
- Predicates its devices cite: 3 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Kenpax International Limited: 1 (https://510kreport.com/company/kenpax-international)
- Medline Industires, Inc.: 1 (https://510kreport.com/company/medline-industires)

## Its most-cited devices
- K222898: SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (2022), cited by 1

## Recent decisions
- K250502: SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (AMERI-TUFF Series 4000, AMERI-TOUCH Series 5000) (Mar 19, 2025)
- K222898: SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (Nov 7, 2022)
- K221134: Procedure Mask with Ear Loops and Surgical Mask with Ties (May 19, 2022)

Source page: https://510kreport.com/company/safesource-direct