# K202358: Protective Face Mask for Medical Use

- Pathway: 510(k) (Traditional)
- Applicant: Hunan Heng Chang Pharmaceutical Co., Ltd.
- Decided: Jan 29, 2021 after 163 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.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143287: Fluidshield* Surgical Mask with Expanded Chamber, Halyard Health, Inc. (2015) Summary page 4.

## Indications for use
The Protective Face Mask for Medical Use is intended to worn by the healthcare personnel during procedure to protect both the patient and the healthcare personnel from the 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(s), provided non-sterile/sterile.

Source page: https://510kreport.com/device/K202358
Methodology: https://510kreport.com/methodology