# K210030: Medical Surgical Mask

- Pathway: 510(k) (Traditional)
- Applicant: Tianjin Aoshang Outdoor Equipment Co., Ltd.
- Decided: Apr 23, 2021 after 108 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). 17 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201479: DemeMASK, Demetech Corporation (2020) Summary page 5.
- K153496: Disposable Surgical Face Mask, Xiantao Rayxin Medical Products Co., Ltd. (2016) Summary page 5.

## Most influential descendants
- K220597: Disposable Surgical Face Mask (FM-34EE,FM-44EE) (2022), 1 descendant of its own
- K252830: Disposable Surgical Face Mask (3P00B, C2900) (2026), 0 descendants of its own
- K231719: Medical Surgical Mask (2024), 0 descendants of its own
- K212299: Medical Surgical Mask (2022), 0 descendants of its own

## Indications for use
The Medical Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These surgical 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, provided non-sterile.

Source page: https://510kreport.com/device/K210030
Methodology: https://510kreport.com/methodology