# K212807: Surgical Masks

- Pathway: 510(k) (Traditional)
- Applicant: Weihai Hongyu Nonwoven Fabric Products Co., Ltd.
- Decided: Dec 3, 2021 after 91 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: 9 generations back to K874608 (1987). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202594: Medical Surgical Masks-Non Sterile, Shandong T&F Nonwoven Co., Ltd. (2021) Summary page 5.

## Indications for use
The Surgical Masks is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Surgical Masks 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(s), provided non-sterile. The Model YH-EZ-004(White Color, Blue Color) is Level 2 barrier as ASTM F2100 requirements.

Source page: https://510kreport.com/device/K212807
Methodology: https://510kreport.com/methodology