# K201729: Medical Mask

- Pathway: 510(k) (Traditional)
- Applicant: Zhende Medical Co., Ltd.
- Decided: Dec 3, 2020 after 162 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: 4 generations back to K874608 (1987). 6 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110455: Kimberly-Clark Low Barrier, Astm 2100 Face Masks, Kimberly-Clark Corp. (2011) Summary page 4.

## Most influential descendants
- K214087: Medical Face Mask (2022), 2 descendants of its own
- K222809: Medical Disposable Face Masks (2023), 1 descendant of its own
- K240258: Disposable Medical Face Mask (M643BE) (2024), 0 descendants of its own
- K203012: Surgical Mask (2021), 0 descendants of its own
- K202708: Surgical Face Masks (2021), 0 descendants of its own

## Indications for use
The Medical 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 of the wearer to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.

Source page: https://510kreport.com/device/K201729
Methodology: https://510kreport.com/methodology