# K210643: Disposable Surgical Face Mask

- Pathway: 510(k) (Traditional)
- Applicant: Shandong Zhushi Pharmaceutical Group Co., Ltd.
- Decided: Aug 4, 2021 after 154 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). 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)
- K203200: Disposable Medical Surgical Face Mask, Guangdong Haiou Medical Apparatus Co., Ltd. (2021). Cleared while this submission was under review Summary page 5.

## Indications for use
The Disposable Surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. This face mask is 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/K210643
Methodology: https://510kreport.com/methodology