# K212120: Surgical Masks

- Pathway: 510(k) (Traditional)
- Applicant: Hubei Xinxin Non-Woven Co., Ltd.
- Decided: Jan 28, 2022 after 205 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.
1 later device descends from it; 1 cites it directly.
0 of 10 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 6.

## Most influential descendants
- K212330: Yadu Medical Face Mask (Level 1) (2022), 0 descendants of its own

## Indications for use
The surgical masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These 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. XX0009 Ear loop Level: Level 1, Level 2 and Level 3 XX0008 Tie-on Level: Level 1, Level 2 and Level 3 XX0006 Tie-on with shield Level: Level 1, Level 2 and Level 3 XX0005 Ear loop with shield Level: Level 1, Level 2 and Level 3

Source page: https://510kreport.com/device/K212120
Methodology: https://510kreport.com/methodology