# K202905: Disposable Face Mask

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Excellence Medical Supplies Co., Ltd.
- Decided: Mar 26, 2021 after 178 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.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160269: Surgical Face Masks (Ear loops and Tie-on), San-M Package Co., Ltd. (2016) Summary page 5.

## Most influential descendants
- K212997: Surgical Mask (2022), 0 descendants of its own

## Indications for use
The Disposable Face 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 the potential exposure to blood and body fluids. This is a single-use, disposable device, provided non-sterile.

Source page: https://510kreport.com/device/K202905
Methodology: https://510kreport.com/methodology