# K971744: Floor Mask-Ear Loop (BMR-15011)/Floor Mask-Tie (BMR-1503)

- Pathway: 510(k) (Traditional)
- Applicant: Berkley Medical Resources, Inc.
- Decided: Jul 28, 1997 after 77 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 BMR - 1501, 1503 Surgical Face Mask is a surgical apparel device that is intended to be worn by operating personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of mjcrmorganisms body fluids, and particulate material. The BMR - 1501, 1503 Surgical Face Mask is intended to be used in the above application as a single use disposable device.

Source page: https://510kreport.com/device/K971744
Methodology: https://510kreport.com/methodology