# K203425: Surgical Mask

- Pathway: 510(k) (Traditional)
- Applicant: Bdc Dental Corporation, Ltd.
- Decided: Mar 5, 2021 after 105 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: 5 generations back to K874608 (1987). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051291: Non-Sterile Surgical Mask, A.R. Medicom, Inc. (2005) Summary page 4.

## Indications for use
The surgical masks are intended to be worn by personnel during medical and surgical procedures to protect both the patient and the operating personnel from transfer of microorganisms, body fluids and particulate material. The mask is a single use, disposable device, provided non-sterile.

Source page: https://510kreport.com/device/K203425
Methodology: https://510kreport.com/methodology