# K230093: Disposable 4 Layers Surgical Face Mask

- Pathway: 510(k) (Traditional)
- Applicant: Social Medical Supply, LLC
- Decided: Mar 2, 2023 after 49 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: 12 generations back to K874608 (1987). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221272: Medical Face Mask, Shandong Xingyu Gloves Co., Ltd. (2022) Summary page 5.

## Indications for use
The Disposable 4 layers surgical face mask is intended to be worn by adults, and protects both patients and healthcare personnel from microorganisms, body fluids and particulate material transfer within a professional healthcare environment. The mask is designed for use in infection control practices to reduce the potential exposure to blood and body fluids. It is a single-use, disposable device(s), and provided non-sterile.

Source page: https://510kreport.com/device/K230093
Methodology: https://510kreport.com/methodology