# K211897: Surgical Face Mask

- Pathway: 510(k) (Traditional)
- Applicant: Zhejiang Hongyu Medicali Commodity Co., Ltd.
- Decided: Aug 3, 2021 after 43 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: 9 generations back to K874608 (1987). 11 ancestors in all.
1 later device descends from it; 1 cites 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)
- K182515: Surgical Face Mask, Wuhan Dymex Healthcare Co., Ltd. (2019) Summary page 5.

## Most influential descendants
- K213970: D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply (2022), 0 descendants of its own

## Indications for use
The Surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. This face mask 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, provided non-sterile.

Source page: https://510kreport.com/device/K211897
Methodology: https://510kreport.com/methodology