# K210063: Freudenberg Surgical Mask

- Pathway: 510(k) (Traditional)
- Applicant: Freudenberg Performance Materials LP
- Decided: Feb 5, 2021 after 25 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: 9 generations back to K874608 (1987). 11 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182514: Surgical Face Mask, Xiantao Zhibo Non-Woven Products Co., Ltd. (2019) Summary page 4.

## Most influential descendants
- K212111: Myflon Surgical Mask Level 3 (2022), 0 descendants of its own
- K212109: Spin Care Disposable Protective Mask Level 3 (2021), 0 descendants of its own

## Indications for use
The Freudenberg Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. This face mask is 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/K210063
Methodology: https://510kreport.com/methodology