# K222266: Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80)

- Pathway: 510(k) (Traditional)
- Applicant: Jingzhou Haixin Green Cross Medical Products Co., Ltd.
- Decided: Sep 26, 2022 after 60 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: 8 generations back to K874608 (1987). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210147: Unico High Performance Surgical Mask, Unico High Performance Surgical Mask with Face Shield, Unicoglobal, Inc. (2021) Summary page 4.

## Indications for use
The Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The medical surgical mask is 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/K222266
Methodology: https://510kreport.com/methodology