# K191355: 3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask

- Pathway: 510(k) (Traditional)
- Applicant: 3M Healthcare
- Decided: Sep 11, 2019 after 113 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). 8 ancestors in all.
12 later devices descend from it; 10 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131879: KC 300 Surgical Mask, Kimberly-Clark Corp. (2013) Summary page 4.

## Most influential descendants
- K210147: Unico High Performance Surgical Mask, Unico High Performance Surgical Mask with Face Shield (2021), 1 descendant of its own
- K201924: Single-Use Surgical Mask (2021), 1 descendant of its own
- K251902: Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield (Vitaform-FS) (2025), 0 descendants of its own
- K222749: High Fluid-Resistant Surgical and Procedure Mask (2022), 0 descendants of its own
- K222266: Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80) (2022), 0 descendants of its own

## Indications for use
The 3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant 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 single use, disposable device, provided non-sterile.

Source page: https://510kreport.com/device/K191355
Methodology: https://510kreport.com/methodology