# K223236: Medline Surgical Face Mask and Medline Procedural Face Mask

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, LP
- Decided: Mar 24, 2023 after 156 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)
- K202598: 3 Layer Surgical Mask with Ear Loops Level 1, 3 Layer Surgical Mask with Ties Level 1, 3 Layer Surgical Mask with Ear Loops Level 2, 3 Layer Surgical Mask with Ties Level 2, 3 Layer Surgical Mask with Ear Loops Level 3, 3 Layer Surgical Marks with Ties Level 3, 3A Medical Products Co., Ltd. (2021) Summary page 4.

## Indications for use
The Medline Surgical Face Mask and Medline Procedural Face Mask are intended to be worn to protect both the patient and the healthcare worker from the 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. These masks are single use, disposable, non-sterile devices.

Source page: https://510kreport.com/device/K223236
Methodology: https://510kreport.com/methodology