# K210845: Disposable Surgical Mask (Model: YYKZ-01)

- Pathway: 510(k) (Traditional)
- Applicant: Jiaxing Amazing Travel-Ware Co., Ltd.
- Decided: Oct 12, 2021 after 204 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: 7 generations back to K874608 (1987). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202061: Medical Face mask, Jiangsu Province Jianerkang Medical Dressing Co., Ltd. (2020) Summary page 4.

## Indications for use
The DISPOSABLE SURGICAL MASK is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate materials in infection control practices to reduce the potential exposure to blood and body fluids. It is for single- use and provided non-sterile.

Source page: https://510kreport.com/device/K210845
Methodology: https://510kreport.com/methodology