# K210102: Topwide Surgical Face Mask

- Pathway: 510(k) (Traditional)
- Applicant: Topwide (Hubei) Medical Products Manufacturer
- Decided: Dec 17, 2021 after 337 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)
- K201691: Single-Use Surgical Mask With Ear Loop, Qiqihar Hengxin Medical Supplies, Ltd. (2020) Summary page 4.

## Indications for use
The TOPWIDE surgical face mask is intended to be worn to protect both patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The TOPWIDE surgical intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This device is non-sterile and for single use only.

Source page: https://510kreport.com/device/K210102
Methodology: https://510kreport.com/methodology