Safesource Direct, LLC is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Safesource Direct, LLC - FDA 510(k) Cleared Devices
Recent clearances: SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (AMERI-TUFF Series 4000, AMERI-TOUCH Series 5000), SafeSource Direct Blue Powder-Free Nitrile Exam Gloves, Procedure Mask with Ear Loops and Surgical Mask with Ties
3
Total
3
Cleared
0
Denied
Safesource Direct, LLC has 3 FDA 510(k) cleared medical devices. Based in Broussard, US.
Latest FDA clearance: Mar 2025. Active since 2022. Primary specialty: General Hospital.
Browse the FDA 510(k) cleared devices submitted by Safesource Direct, LLC Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Regulatory Technology Services, LLC and Powers Regulatory Consulting.
FDA 510(k) Regulatory Record - Safesource Direct, LLC
3 devices
Cleared
Mar 19, 2025
SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (AMERI-TUFF Series...
General Hospital
27d
Cleared
Nov 07, 2022
SafeSource Direct Blue Powder-Free Nitrile Exam Gloves
General Hospital
45d
Cleared
May 19, 2022
Procedure Mask with Ear Loops and Surgical Mask with Ties
General Hospital
30d