# K212460: Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm))

- Pathway: 510(k) (Traditional)
- Applicant: Guangzhou Zhengkang Medical Equipment Co.,Ltd
- Decided: Nov 5, 2021 after 92 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: 2 generations back to K911334 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200847: Surgical Face Mask, Mexpo International, Inc. (2020) Summary page 4.

## Indications for use
Medical Surgical Mask is intended to be worn to protect both patients and healthcare workers against transfer of microorganisms, body fluids and particulate materials. This is a single use device, provided non-sterile.

Source page: https://510kreport.com/device/K212460
Methodology: https://510kreport.com/methodology