# K210007: Face Mask

- Pathway: 510(k) (Traditional)
- Applicant: Jinhua Jingdi Medical Supplies Co., Ltd.
- Decided: Apr 23, 2021 after 109 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.
1 later device descends from it; 1 cites 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)
- K182514: Surgical Face Mask, Xiantao Zhibo Non-Woven Products Co., Ltd. (2019) Summary page 5.

## Most influential descendants
- K210244: Disposable Medical Face Mask (2021), 0 descendants of its own

## Indications for use
The 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. The Face Masks are single use, disposable devices, provided non-sterile.

Source page: https://510kreport.com/device/K210007
Methodology: https://510kreport.com/methodology