# K213970: D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply

- Pathway: 510(k) (Traditional)
- Applicant: Danameco Medical Joint Stock Corporation
- Decided: Jan 23, 2022 after 34 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: 10 generations back to K874608 (1987). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211897: Surgical Face Mask, Zhejiang Hongyu Medicali Commodity Co., Ltd. (2021) Summary page 5.

## Indications for use
The D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The surgical face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. These are single use, disposable devices, provided non-sterile.

Source page: https://510kreport.com/device/K213970
Methodology: https://510kreport.com/methodology