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
FDA 510(k) Regulatory Record - Safesource Direct, LLC General Hospital ✕
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