# K211249: Altor Safety 3-Ply Surgical Mask (Model:62222)

- Pathway: 510(k) (Traditional)
- Applicant: Altor Safety, LLC
- Decided: Jul 23, 2021 after 88 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: 10 generations back to K874608 (1987). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202463: Disposable Surgical Mask, Unisources Group, LLC (2020) Summary page 5.

## Indications for use
The Altor Safety 3-Ply Surgical Mask (Model:62222) is intended to be worn to protect both the patient and healthcare professional from transfer of microorganisms, body fluids, and particulate material. The Altor Safety 3-Ply 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, non-sterile, disposable device.

Source page: https://510kreport.com/device/K211249
Methodology: https://510kreport.com/methodology