# K203756: Disposable Surgical Mask

- Pathway: 510(k) (Traditional)
- Applicant: Lucky Textile Industrial (Wuxi) Co., Ltd.
- Decided: Jun 10, 2021 after 169 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: 2 generations back to K911334 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200847: Surgical Face Mask, Mexpo International, Inc. (2020) Summary page 5.

## Indications for use
When properly worn, the surgical face masks are intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and particulate materials. This device is non sterile and for single use only.

Source page: https://510kreport.com/device/K203756
Methodology: https://510kreport.com/methodology