# K201537: Protective Face Mask for Medical Use

- Pathway: 510(k) (Traditional)
- Applicant: Shandong Shengquan New Material Co., Ltd.
- Decided: Sep 4, 2020 after 88 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.
4 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143287: Fluidshield* Surgical Mask with Expanded Chamber, Halyard Health, Inc. (2015) Summary page 4.

## Most influential descendants
- K212205: Medical Protective Masks (2021), 1 descendant of its own
- K202107: Medical Protective Mask (2021), 1 descendant of its own
- K223686: Medical Protective Masks (2023), 0 descendants of its own
- K212740: Puravita Medical Fold Flat Surgical Mask (2021), 0 descendants of its own

## Indications for use
The Protective Face Mask for Medical Use is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The face mask is 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.

Source page: https://510kreport.com/device/K201537
Methodology: https://510kreport.com/methodology