# K171162: Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap Shield

- Pathway: 510(k) (Abbreviated)
- Applicant: Prestige Ameritech
- Decided: Aug 15, 2017 after 117 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Surgical Earloop Face Mask with Bottom Gap Shield 7410E and Surgical Tie-On Face Mask with Bottom Gap Shield 7410T are single use disposable devices intended to be worn in the operating room as well as dental, isolation and other medical procedures to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material.

Source page: https://510kreport.com/device/K171162
Methodology: https://510kreport.com/methodology