# K211762: Altor Safety 4-Ply Surgical Mask (Model:62232)

- Pathway: 510(k) (Traditional)
- Applicant: Altor Safety, LLC
- Decided: Sep 3, 2021 after 87 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.
1 later device descends from it; 1 cites it directly.
0 of 11 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.

## Most influential descendants
- K221209: PRECISION ECO Compostable / Plant Based Procedural Mask with Earloops (2023), 0 descendants of its own

## Indications for use
The Altor Safety 4-Ply Surgical Mask 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 4-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/K211762
Methodology: https://510kreport.com/methodology