# K202903: Surgical Face Mask

- Pathway: 510(k) (Traditional)
- Applicant: Rizhao Sanqi Medical & Health Articles Co., Ltd.
- Decided: Mar 24, 2022 after 541 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: 6 generations back to K874608 (1987). 8 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160269: Surgical Face Masks (Ear loops and Tie-on), San-M Package Co., Ltd. (2016) Summary page 5.

## Most influential descendants
- K252650: Disposable Medical Face Mask (2026), 0 descendants of its own
- K221352: Surgical Face Mask (2023), 0 descendants of its own

## Indications for use
The Surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. When worn properly, these face 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, provided non-sterile. Level 1 Surgical Face Mask models: SQ-1001 Level 2 Surgical Face Mask models: SQ-2001, SQ-2001H, SQ-2004, SQ-2004H Level 3 Surgical Face Mask models: SQ-3001, SQ-3001H

Source page: https://510kreport.com/device/K202903
Methodology: https://510kreport.com/methodology