# K212203: Dong Hai Xiang Surgical Mask

- Pathway: 510(k) (Traditional)
- Applicant: Taizhou Donghaixiang Protective Equipment Co., Ltd.
- Decided: Apr 7, 2022 after 267 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: 2 generations back to K911334 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200847: Surgical Face Mask, Mexpo International, Inc. (2020) Summary page 4.

## Indications for use
Dong Hai Xiang Surgical Mask is intended for use in healthcare settings, procedures during which a face mask is necessary to protect both patient and healthcare personnel from transfer of body fluids, microorganisms, and particulate material. The device is indicated to be over-the-counter use. adult only. The device is disposable and is indicated for single use. The device is not provided sterile

Source page: https://510kreport.com/device/K212203
Methodology: https://510kreport.com/methodology