# K243342: KP Protective Face Mask

- Pathway: 510(k) (Traditional)
- Applicant: Kp Trading Co., Ltd.
- Decided: Dec 22, 2025 after 423 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: 3 generations back to K063023 (2007). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172500: Technoweb Surgical Mask, Yts Global, Inc. (2018) Summary page 5.

## Indications for use
The KP Protective Face Mask is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and operating room personnel from transfer of microorganisms, body fluids, and particulate material.

Source page: https://510kreport.com/device/K243342
Methodology: https://510kreport.com/methodology