# K201924: Single-Use Surgical Mask

- Pathway: 510(k) (Traditional)
- Applicant: Qiqihar Hengxin Medical Supplies, Ltd.
- Decided: Mar 15, 2021 after 248 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: 7 generations back to K874608 (1987). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191355: 3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask, 3M Healthcare (2019) Summary page 6.

## Most influential descendants
- K214094: ROKI Surgical Mask (2022), 0 descendants of its own

## Indications for use
The Single-Use Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Single-Use Surgical Mask 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. Model: M and L, blue color, and Level 3 barrier level as ASTM F2100

Source page: https://510kreport.com/device/K201924
Methodology: https://510kreport.com/methodology