Medical Device Manufacturer · TR , Istanbul

Flomak Tekstil Makine Muh. Mum. Taah. San. Tic. Ltd. Sti. - FDA 510(k...

1 submissions · 1 cleared · Since 2022

Recent clearances: Flosteril Poly-reinforced Isolation Gowns Model 8120 (Catalogue Number 8120400), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120410), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120430), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120450), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120460)

1

Total

1

Cleared

0

Denied

FDA 510(k) Regulatory Record - Flomak Tekstil Makine Muh. Mum. Taah. San. Tic. Ltd. Sti. General Hospital ✕

1 devices

1-1 of 1

Cleared Apr 13, 2022

Flosteril Poly-reinforced Isolation Gowns Model 8120 (Catalogue Number...

General Hospital · 447d

Data Source

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

Last updated: May 21, 2026