Medical Device Manufacturer · MY , Johor Bahru

Durio Ppe Sdn Bhd - FDA 510(k) Cleared Devices

1 submissions · 1 cleared · Since 2023

Recent clearances: Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue)

1

Total

1

Cleared

0

Denied

FDA 510(k) Regulatory Record - Durio Ppe Sdn Bhd General Hospital ✕

1 devices

1-1 of 1

Cleared Jul 17, 2023

Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue)

General Hospital · 153d

Data Source

Sourced from the FDA 510(k) public files . 175,450 total devices indexed.

Last updated: May 17, 2026