# K202387: Disposable Surgical Face Mask

- Pathway: 510(k) (Traditional)
- Applicant: Guangdong Bida Medical Technology Co., Ltd.
- Decided: Apr 23, 2021 after 245 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). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160269: Surgical Face Masks (Ear loops and Tie-on), San-M Package Co., Ltd. (2016) Summary page 5.
- K191355: 3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask, 3M Healthcare (2019) Summary page 5.

## Indications for use
Disposable Surgical Face Mask is intended to be worn to protect both patients and healthcare personnel from transfer of microorganisms, blood and body fluids, and particulates material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. The face mask is single use, disposable devices provide non-sterile.

Source page: https://510kreport.com/device/K202387
Methodology: https://510kreport.com/methodology