# K034015: Earloop Procedure Mask

- Pathway: 510(k) (Traditional)
- Applicant: Medipack Medical Packaging Mfg. Co.
- Decided: Feb 20, 2004 after 58 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
A Surgical Mask is a device that is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and operating room personnel from transfer of microorganisms, body fluids, and particulate materials.

Source page: https://510kreport.com/device/K034015
Methodology: https://510kreport.com/methodology