Medical Device Manufacturer · US , Katy , TX

Isikel Manufacturing, LLC - FDA 510(k) Cleared Devices

1 submissions · 1 cleared · Since 2023

1

Total

1

Cleared

0

Denied

FDA 510(k) Regulatory Record - Isikel Manufacturing, LLC General Hospital ✕

1 devices

1-1 of 1

Cleared Oct 02, 2023

Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with...

General Hospital · 83d

Data Source

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

Last updated: May 16, 2026