# K210878: Surgical Face Mask (Model: CM2006, CM2008, A88)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Realtone Medical Appliance Co., Ltd.
- Decided: Sep 28, 2021 after 188 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
Surgical Face Mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, body fluids, and particulate materials.

Source page: https://510kreport.com/device/K210878
Methodology: https://510kreport.com/methodology