# K253398: Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)

- Pathway: 510(k) (Special)
- Applicant: Efofex, Inc.
- Decided: Feb 19, 2026 after 142 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: 9 generations back to K874608 (1987). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223823: Disposable Surgical Face Mask, Efofex, Inc. (2023) Summary page 6.

## Indications for use
This single use surgical mask EFX3PLBLKMSK300 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 to blood and body fluids. This is a single use, disposal device, provided non-sterile.

Source page: https://510kreport.com/device/K253398
Methodology: https://510kreport.com/methodology