# K202843: Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile)

- Pathway: 510(k) (Traditional)
- Applicant: B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.
- Decided: Jan 12, 2021 after 109 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 K970835 (1997). 6 ancestors in all.
5 later devices descend from it; 5 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173062: Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties)), V&Q Manufacturing Corporation (2018) Summary page 6.

## Most influential descendants
- K233723: Medical surgical mask (2024), 0 descendants of its own
- K222335: Surgical Mask (2022), 0 descendants of its own
- K211750: Disposable Surgical Face Mask, Disposable Surgical Face Mask (Sterile) (2021), 0 descendants of its own
- K211295: Surgical Mask (sterile) (2021), 0 descendants of its own
- K210908: Surgical Mask (2021), 0 descendants of its own

## Indications for use
The Surgical Face Mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.

Source page: https://510kreport.com/device/K202843
Methodology: https://510kreport.com/methodology