# K212997: Surgical Mask

- Pathway: 510(k) (Traditional)
- Applicant: Guangdong Zhizhen Biological Medical Co., Ltd.
- Decided: Jan 14, 2022 after 116 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: 7 generations back to K874608 (1987). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202905: Disposable Face Mask, Jiangsu Excellence Medical Supplies Co., Ltd. (2021) Summary page 5.

## Indications for use
The surgical mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These 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. Serial number: ZZ-YYKZ-01, size 175x95mm, Blue ZZ-YYKZ-02, size 145x95mm, Blue ZZ-YYKZ-03, size 175x95mm, Black ZZ-YYKZ-04, size 145x95mm, Black

Source page: https://510kreport.com/device/K212997
Methodology: https://510kreport.com/methodology