# K240258: Disposable Medical Face Mask (M643BE)

- Pathway: 510(k) (Traditional)
- Applicant: Makrite Industries, Inc.
- Decided: Apr 18, 2024 after 78 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: 7 generations back to K874608 (1987). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222809: Medical Disposable Face Masks, Anqing Mayfield Medical Limited (2023) Summary page 5.

## Indications for use
The Disposable Medical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The Disposable Medical Face Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This a single use, disposable device(s), provided non-sterile.

Source page: https://510kreport.com/device/K240258
Methodology: https://510kreport.com/methodology