Medical Device Manufacturer · KR , Seongnam

Unicoglobal, Inc. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2021

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Unicoglobal, Inc. General Hospital ✕

2 devices

1-2 of 2

Cleared Dec 22, 2021

Unico High Performance Surgical Mask, Unico High Performance Surgical Mask...

General Hospital · 335d

Cleared Dec 10, 2021

Unico Global level 3 Surgical Gown (Film-reinforced SMS), Unico Global Level...

General Hospital · 372d

Data Source

Sourced from the FDA 510(k) public files . 174,883 total devices indexed.

Last updated: May 23, 2026