# K220597: Disposable Surgical Face Mask (FM-34EE,FM-44EE)

- Pathway: 510(k) (Traditional)
- Applicant: Qingdao Bestex Rubber & Plastic Products Co., Ltd.
- Decided: May 26, 2022 after 86 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). 18 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210030: Medical Surgical Mask, Tianjin Aoshang Outdoor Equipment Co., Ltd. (2021) Summary page 4.

## Most influential descendants
- K252830: Disposable Surgical Face Mask (3P00B, C2900) (2026), 0 descendants of its own

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

Source page: https://510kreport.com/device/K220597
Methodology: https://510kreport.com/methodology