# K203200: Disposable Medical Surgical Face Mask

- Pathway: 510(k) (Traditional)
- Applicant: Guangdong Haiou Medical Apparatus Co., Ltd.
- Decided: Jun 16, 2021 after 230 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: 8 generations back to K874608 (1987). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201137: Asept Surgical Face Mask, Pfm Medical, Inc. (2020) Summary page 5.

## Most influential descendants
- K210643: Disposable Surgical Face Mask (2021), 0 descendants of its own

## Indications for use
Disposable Medical Surgical Face Mask is indicated as a protective nose and mouth covering for healthcare workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of exposure to microorganisms and body fluids.

Source page: https://510kreport.com/device/K203200
Methodology: https://510kreport.com/methodology