# K153409: Protect U Guard Earloop and Tie-On Mask (Blue, White or Green)

- Pathway: 510(k) (Abbreviated)
- Applicant: Protect U Guard, LLC
- Decided: Nov 15, 2016 after 356 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: 5 generations back to K970835 (1997). 5 ancestors in all.
7 later devices descend from it; 5 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122717: Face Mask, Surgical Mask, Procedure Mask, Surgical Face Mask, Tiger Medical Products, Ltd. (2012) Summary page 7.

## Most influential descendants
- K201622: Medical surgical mask (2020), 2 descendants of its own
- K231155: Biodegradable Medical surgical mask (2023), 0 descendants of its own
- K213450: Medical surgical mask (Black mask, Level 1 and Level 3) (2022), 0 descendants of its own
- K203388: Disposable medical mask (2021), 0 descendants of its own
- K201095: Sovereign America Surgical Face Mask (2021), 0 descendants of its own

## Indications for use
Earloop Mask and Tie-On Mask is intended for use by healthcare workers during procedures to protect both patients and healthcare workers against transfer of microorganisms, bodily fluids, and airborne particles. This device is single-use and provided non-sterile. Earloop Models: Blue (P10031), White (P10032), or Green (P10033) Tie-On Models: Blue (P10041), White (P10042), or Green (P10043)

Source page: https://510kreport.com/device/K153409
Methodology: https://510kreport.com/methodology