# K202126: Disposable Surgical Mask

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Peninsula Medical Co., Ltd.
- Decided: Jun 8, 2021 after 312 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: 5 generations back to K970835 (1997). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123115: Acme Surgical Face Mask with Ear-Loop Model YN-501 AB/W/G/P, Acme Filter Mask, Inc. (2013) Summary page 5.

## Indications for use
Disposable Surgical Mask is Device that is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operation room personnel from transfer of microorganisms, body fluids and particulate material.

Source page: https://510kreport.com/device/K202126
Methodology: https://510kreport.com/methodology