# K203012: Surgical Mask

- Pathway: 510(k) (Abbreviated)
- Applicant: Customfab, Inc.
- Decided: Apr 11, 2021 after 192 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). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201729: Medical Mask, Zhende Medical Co., Ltd. (2020). Cleared while this submission was under review Summary page 5.

## Indications for use
The Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material in infection control practices to reduce the potential exposure of the wearer to blood and body fluids. This is a single use device, provided non-sterile.

Source page: https://510kreport.com/device/K203012
Methodology: https://510kreport.com/methodology