# K210422: INTAI Surgical Mask (non-sterile)

- Pathway: 510(k) (Traditional)
- Applicant: Intai Technology Corp.
- Decided: Mar 30, 2022 after 412 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: 10 generations back to K874608 (1987). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210218: SURGICAL MASK, Model Name:C015, Qingdao Hainuo Biological Engineering Co., Ltd. (2021). Cleared while this submission was under review Summary page 4.

## Indications for use
INTAI Surgical Mask is intended to be worn 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. This is a single use, disposable device and provided non-sterile.

Source page: https://510kreport.com/device/K210422
Methodology: https://510kreport.com/methodology