# K212740: Puravita Medical Fold Flat Surgical Mask

- Pathway: 510(k) (Traditional)
- Applicant: Puravita M, LLC
- Decided: Dec 2, 2021 after 94 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.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202107: Medical Protective Mask, Guangdong Kingfa Sci. & Tech.Co., Ltd. (2021) Summary page 4.

## Indications for use
The Puravita Medical Fold Flat Surgical Mask is intended to be worn to protect both patients and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. The Puravita Medical Fold Flat Surgical 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 that is provided non-sterile.

Source page: https://510kreport.com/device/K212740
Methodology: https://510kreport.com/methodology