# K210622: Single-Use Medical Face Mask

- Pathway: 510(k) (Traditional)
- Applicant: Jiangxi Hongda Medical Equipment Group Co., Ltd.
- Decided: Oct 8, 2021 after 220 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
- K223068: Medical Protective Mask (model: 8862, 8862A, 8862B, 8862C, 8862D, 8862E) (2022), 0 descendants of its own

## Indications for use
The single-use medical face masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. 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 sterile and non-sterile. Level 1 mask Models: Sterile Tie-on, Sterile Ear loop, Non-sterile Tie-on, Non-sterile Ear loop Level 2 mask Models: Sterile Tie-on, Sterile Ear loop, Non-sterile Tie-on, Non-sterile Ear loop Level 3 mask Models: Sterile Tie-on, Sterile Ear loop, Non-sterile Tie-on, Non-sterile Ear loop

Source page: https://510kreport.com/device/K210622
Methodology: https://510kreport.com/methodology