# K232797: Hygenix

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Hygenix Industrial Co., Ltd.
- Decided: Dec 11, 2023 after 90 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: 11 generations back to K874608 (1987). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221196: Disposable Medical Face Mask (ear loop), Xiantao Topmed Nonwoven Protective Products Co., Ltd. (2022) Summary page 6.

## Indications for use
The Hygenix is intended to be worn to protect both the patient and health care 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 device is disposable, non-sterile and for single use only.

Source page: https://510kreport.com/device/K232797
Methodology: https://510kreport.com/methodology