# K223823: Disposable Surgical Face Mask

- Pathway: 510(k) (Traditional)
- Applicant: Efofex, Inc.
- Decided: Mar 27, 2023 after 96 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: 8 generations back to K874608 (1987). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202761: Medical Surgical Mask (Non-sterile), Guangdong Goodfeeling Hygiene Material Tec Co., Ltd. (2021) Summary page 4.

## Most influential descendants
- K253398: Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300) (2026), 0 descendants of its own

## Indications for use
This single-use surgical mask EFXPLY3SMSK is intended to be worn to protect both the patient and health care personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure of blood and body fluids. This is a single use, disposable device, non-sterile.

Source page: https://510kreport.com/device/K223823
Methodology: https://510kreport.com/methodology