# K252830: Disposable Surgical Face Mask (3P00B, C2900)

- Pathway: 510(k) (Traditional)
- Applicant: Beatles Medical Supplies (Xiantao) Co., Ltd.
- Decided: Jan 12, 2026 after 129 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). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220597: Disposable Surgical Face Mask (FM-34EE,FM-44EE), Qingdao Bestex Rubber & Plastic Products Co., Ltd. (2022) Summary page 5.

## 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/K252830
Methodology: https://510kreport.com/methodology