Dukal Corporation

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
7
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K212464Dukal Corporation AAMI Level 4 Open-Back Protective GownMarch 30, 2022
K210321Dukal Corporation Level 1 Pediatric Face MaskMarch 29, 2022
K203237Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMMarch 18, 2022
K201732Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical FaceFebruary 16, 2021
K201421Dukal Corporation Level 2 Surgical Mask with Ear Loops; Dukal Corporation Level 2 Surgical Mask withFebruary 5, 2021
K113689DUKAL LUBRICATING JELLYMay 4, 2012
K070692DUKAL N95PARTICULATE RESPIRATOR/SURGICAL FACE MASKMay 30, 2007