# K182515: Surgical Face Mask

- Pathway: 510(k) (Traditional)
- Applicant: Wuhan Dymex Healthcare Co., Ltd.
- Decided: May 27, 2019 after 257 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.
50 later devices descend from it; 34 cite it directly.
0 of 61 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
- K210433: Surgical Face Mask (Ear loops and Tie-on) (2021), 5 descendants of its own
- K202463: Disposable Surgical Mask (2020), 4 descendants of its own
- K202595: Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask (2021), 3 descendants of its own
- K221196: Disposable Medical Face Mask (ear loop) (2022), 1 descendant of its own
- K212344: Surgical Mask (2021), 1 descendant of its own

## Indications for use
The 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/K182515
Methodology: https://510kreport.com/methodology