# K222749: High Fluid-Resistant Surgical and Procedure Mask

- Pathway: 510(k) (Traditional)
- Applicant: America’S Supply Chains
- Decided: Nov 14, 2022 after 63 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)
- K191355: 3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask, 3M Healthcare (2019) Summary page 4.

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

Source page: https://510kreport.com/device/K222749
Methodology: https://510kreport.com/methodology