# K202211: Disposable Medical Surgical Face Masks

- Pathway: 510(k) (Traditional)
- Applicant: Guangdong Kaidi Garments Co.,Ltd
- Decided: Dec 22, 2020 after 138 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). 10 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153496: Disposable Surgical Face Mask, Xiantao Rayxin Medical Products Co., Ltd. (2016) Summary page 4.

## Most influential descendants
- K203078: CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW (2022), 0 descendants of its own
- K220487: Disposable Medical Face Mask (2022), 0 descendants of its own
- K210815: Disposable Face Mask (2021), 0 descendants of its own

## Indications for use
The Disposable Medical Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face 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/K202211
Methodology: https://510kreport.com/methodology