# K202719: Disposable Medical Face Masks

- Pathway: 510(k) (Traditional)
- Applicant: Jiangxi Sanxin Medtec Co., Ltd.
- Decided: Jan 4, 2021 after 109 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). 16 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 19 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 5.
- K173062: Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties)), V&Q Manufacturing Corporation (2018) Summary page 5.

## Most influential descendants
- K203591: Single-use Medical Face Mask (2021), 1 descendant of its own
- K203112: Disposable Medical Mask (2021), 0 descendants of its own

## Indications for use
The non-sterile disposable medical face masks are 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 the potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile. The sterile disposable medical face masks are intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.

Source page: https://510kreport.com/device/K202719
Methodology: https://510kreport.com/methodology