# K230380: Surgical Face Masks, Model: EFMDS-L50Pn BLU

- Pathway: 510(k) (Traditional)
- Applicant: Iris USA
- Decided: Aug 3, 2023 after 171 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Surgical Face Masks, Model: EFDS-L5-Pn BLU is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. This face mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable mask provided non-sterile.

Source page: https://510kreport.com/device/K230380
Methodology: https://510kreport.com/methodology