# K172500: Technoweb Surgical Mask

- Pathway: 510(k) (Traditional)
- Applicant: Yts Global, Inc.
- Decided: Mar 1, 2018 after 195 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: 2 generations back to K063023 (2007). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121069: 3M Vflex Health Care Particulate Respirator and Surgical Mask, 3M Company (2013) Summary page 4.

## Most influential descendants
- K243342: KP Protective Face Mask (2025), 0 descendants of its own
- K223270: POSE™ Health Care Surgical Mask (2022), 0 descendants of its own

## Indications for use
The Technoweb Sugical Mask is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.

Source page: https://510kreport.com/device/K172500
Methodology: https://510kreport.com/methodology