# K042654: Protection Plus Earloop Procedure Mask

- Pathway: 510(k) (Traditional)
- Applicant: Safety-Med Products, Inc.
- Decided: Dec 17, 2004 after 80 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.
37 later devices descend from it; 1 cites it directly.
0 of 38 devices 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.

## Most influential descendants
- K112440: AB Dental Devices Implants and Accessories (2012), 36 descendants of its own
- K132125: A.B. Dental Devices Dental Implants System (2014), 25 descendants of its own
- K140440: Noris Medical Dental Implants System (2014), 14 descendants of its own
- K151909: Noris Medical Zygomatic Dental Implant System (2016), 7 descendants of its own
- K140728: Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision Implant, Opi - One Piece Implant, Dental Abutments and PR (2014), 6 descendants of its own

## Indications for use
This product is intended to be worn by operating room personnel to protect both the surgical patient and the operating room personnel from the transfer of microorganisms, body fluids and particulate material.

Source page: https://510kreport.com/device/K042654
Methodology: https://510kreport.com/methodology