# K070407: Dukal Surgical Face Mask Tie, Ear Loop, with Shield Yellow & White; Anti Fog Tie, Loop, Shield, Yellow, White, and Blue

- Pathway: 510(k) (Traditional)
- Applicant: Dukal Corp.
- Decided: Mar 26, 2007 after 42 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: 6 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)
- K061864: Dukal Surgical Face Mask Tie-on, Model 1530; Ear Loop, Model 1540; with Shield, Model 1560, Dukal Corp. (2006) Summary page 2.
- K051291: Non-Sterile Surgical Mask, A.R. Medicom, Inc. (2005) Summary page 2.

## Cited in the summary but kept off the family tree
- K040033: ValuMax Blue, Yellow & White Surgical Fog Free & 3 Ply Masks. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The Dukal medical / surgical masks are indicated as a protective nose and mouth covering for healthcare workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of microorganism, body fluid and particulate aerosol transfer.

Source page: https://510kreport.com/device/K070407
Methodology: https://510kreport.com/methodology