# K211255: Surgical Mask

- Pathway: 510(k) (Traditional)
- Applicant: Tianchang Kanghui Protective Products Co, Ltd.
- Decided: Aug 28, 2021 after 124 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: 1 generation back to K203685 (2021). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203685: Disposable Surgical Face Mask, Xiantao Zhongyi Safety & Protection Products Co., Ltd. (2021) Summary page 4.

## Indications for use
The Surgical Mask (model: KH8001& KH8002) 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 a single use, disposable device(s), provided non-sterile.

Source page: https://510kreport.com/device/K211255
Methodology: https://510kreport.com/methodology