# K233022: Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 2 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, White, Regular and Small

- Pathway: 510(k) (Traditional)
- Applicant: Owens & Minor (O&M) Halyard, Inc.
- Decided: Jan 12, 2024 after 112 days
- Product code: MSH (Respirator, 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: 1 generation back to K974068 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974068: PFR95 Particulate Filter Respirator and Surgical Mask Regular Size, PFR95 Particulate Filter Respirator and Surgical, Tecnol Medical Products, Inc. (1997) Summary page 5.

## Indications for use
The HALYARD FLUIDSHIELD N95 Particulate Filter Respirator and Surgical Mask family is intended for use by operating room personnel and other health care workers to protect both the patients and the health care workers from transfer of microorganisms, blood and body fluids, and airborne particulate materials.

Source page: https://510kreport.com/device/K233022
Methodology: https://510kreport.com/methodology