# K231005: Aurelia Surgical Mask ASTM Level 1; Aurelia Surgical Mask ASTM Level 2

- Pathway: 510(k) (Traditional)
- Applicant: Supermax Healthcare Canada-Supermax Medical
- Decided: Dec 5, 2023 after 242 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: 3 generations back to K874608 (1987). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082258: Crosstex Isolite and Isofluid Earloop Face Masks and Isofluid Fogfree Face Masks with and Without Splash Visor, Crosstex International (2008) Summary page 4.

## Indications for use
The Aurelia Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Aurelia Surgical Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile.

Source page: https://510kreport.com/device/K231005
Methodology: https://510kreport.com/methodology