# K200847: Surgical Face Mask

- Pathway: 510(k) (Traditional)
- Applicant: Mexpo International, Inc.
- Decided: Apr 23, 2020 after 23 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: 1 generation back to K911334 (1991). 1 ancestor in all.
14 later devices descend from it; 11 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K911334: Mask, Surgical Apparel, Thai Hospital Products Co., Ltd. (1991) Summary page 4.

## Most influential descendants
- K211105: Ear-Friendly Mask (2021), 2 descendants of its own
- K212398: Surgical Face Mask (Non-sterile) (2021), 1 descendant of its own
- K202615: Nordiwell Medical Face Mask (2020), 1 descendant of its own
- K221682: Ideal Med Pro 3-Ply Disposable Face Mask (2023), 0 descendants of its own
- K222335: Surgical Mask (2022), 0 descendants of its own

## Indications for use
When properly worn, the surgical face masks are intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and airborne particles. This device is non sterile and for single use only.

Source page: https://510kreport.com/device/K200847
Methodology: https://510kreport.com/methodology