# K202594: Medical Surgical Masks-Non Sterile

- Pathway: 510(k) (Traditional)
- Applicant: Shandong T&F Nonwoven Co., Ltd.
- Decided: Jan 6, 2021 after 120 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: 8 generations back to K874608 (1987). 10 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153496: Disposable Surgical Face Mask, Xiantao Rayxin Medical Products Co., Ltd. (2016) Summary page 6.

## Most influential descendants
- K221409: Paneffort 3-ply Surgical and Procedural Masks (2022), 0 descendants of its own
- K212807: Surgical Masks (2021), 0 descendants of its own

## Indications for use
The Medical Surgical Masks-Non Sterile is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Medical Surgical Masks-Non Sterile is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device(s), provided non-sterile.

Source page: https://510kreport.com/device/K202594
Methodology: https://510kreport.com/methodology