# K221209: PRECISION ECO Compostable / Plant Based Procedural Mask with Earloops

- Pathway: 510(k) (Traditional)
- Applicant: Padm Medical, Inc.
- Decided: Mar 8, 2023 after 316 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)
- K211762: Altor Safety 4-Ply Surgical Mask (Model:62232), Altor Safety, LLC (2021) Summary page 5.

## Indications for use
The PRECISION ECO™ Compostable / Plant Based Procedural Mask with Earloops is intended to be worn to protect both the patient and healthcare professional from transfer of microorganisms, body fluids, and particulate material. The PRECISION ECO™ Compostable / Plant Based Procedural Mask with Earloops is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, non-sterile, disposable device.

Source page: https://510kreport.com/device/K221209
Methodology: https://510kreport.com/methodology