# K202491: Disposable Surgical Face Mask

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Newvalue Medical Products Co., Ltd.
- Decided: Jan 6, 2021 after 128 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: 6 generations back to K874608 (1987). 8 ancestors in all.
4 later devices descend 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)
- K160269: Surgical Face Masks (Ear loops and Tie-on), San-M Package Co., Ltd. (2016) Summary page 4.

## Most influential descendants
- K212293: Surgical Mask (Model: WK1701-02A, WK1701-03A, WK1701-04A) (2021), 3 descendants of its own
- K222204: Medical Surgical Mask (2022), 0 descendants of its own
- K221173: Surgical Mask (Model: 0868F, 0866F) (2022), 0 descendants of its own
- K220187: Medical Surgical Mask (Model: JM92, JM92B) (2022), 0 descendants of its own

## Indications for use
The Disposable 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, provided non-sterile.

Source page: https://510kreport.com/device/K202491
Methodology: https://510kreport.com/methodology