# K213601: Surgical Mask

- Pathway: 510(k) (Traditional)
- Applicant: Wuhan Zonsen Medical Products Co., Ltd.
- Decided: Dec 16, 2022 after 396 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)
- K211827: Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F), Zhejiang Lanhine Medical Products, Ltd. (2021) Summary page 4.

## Indications for use
The Surgical Masks (model: ZSFM 23, ZSFM 24) are 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(s), provided non-sterile.

Source page: https://510kreport.com/device/K213601
Methodology: https://510kreport.com/methodology