Medical Device Manufacturer · US , Hauppauge , NY

Dukal Corporation

7 submissions · 7 cleared · Since 2007
7
Total
7
Cleared
0
Denied

Dukal Corporation — FDA 510(k) Submissions

Dukal Corporation has submitted 7 FDA 510(k) premarket notifications since 2007, of which 7 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Mask, Surgical, Respirator, Surgical, Lubricant, Patient, Gown, Surgical, Pediatric/child Facemask . Use the specialty filter in the sidebar to narrow results.

7 devices
1–7 of 7
Dukal Corporation AAMI Level 4 Open-Back Protective Gown
K212464 · QPC Gown, Non-sterile,... · General Hospital
Mar 2022 236d
Dukal Corporation Level 1 Pediatric Face Mask
K210321 · OXZ Pediatric/child Facemask · General Hospital
Mar 2022 418d
Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical Gown, and Sterile AAMI Level 4 Splicing Surgical Gown
K203237 · FYA Gown, Surgical · General Hospital
Mar 2022 500d
Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks with Tie On
K201732 · FXX Mask, Surgical · General Hospital
Feb 2021 236d
Dukal Corporation Level 2 Surgical Mask with Ear Loops; Dukal Corporation Level 2 Surgical Mask with Ear Loops and Face Shield; Dukal Corporation Level 2 Surgical Mask with Adjustable Tie Ons
K201421 · FXX Mask, Surgical · General Hospital
Feb 2021 252d
DUKAL LUBRICATING JELLY
K113689 · KMJ Lubricant, Patient · General Hospital
May 2012 141d
DUKAL N95PARTICULATE RESPIRATOR/SURGICAL FACE MASK
K070692 · MSH Respirator, Surgical · General Hospital
May 2007 78d
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