# K201732: Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks with Tie On

- Pathway: 510(k) (Traditional)
- Applicant: Dukal Corporation
- Decided: Feb 16, 2021 after 236 days
- Product code: FXX (Mask, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.4040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K874608 (1987). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192374: Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip, Cardinal Health200, LLC (2019) Summary page 5.

## Indications for use
The Dukal Corporation Level 3 Surgical Face Masks are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.

Source page: https://510kreport.com/device/K201732
Methodology: https://510kreport.com/methodology