# K231618: 3 Layer Surgical Mask (134252531)

- Pathway: 510(k) (Traditional)
- Applicant: Original Mattress Factory, Inc.
- Decided: Jul 28, 2023 after 56 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: 10 generations back to K874608 (1987). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202595: Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask, Premier Guard USA, LLC (2021) Summary page 4.

## Indications for use
When properly worn, the 3 Layer Surgical Masks are intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and particulate materials. This device is non sterile and for single use only.

Source page: https://510kreport.com/device/K231618
Methodology: https://510kreport.com/methodology