DeviceClearance

HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops +1 more— 510(k) K251967

Substantially Equivalent

O&M Halyard, Inc.

FDA 510(k) clearance K251967 for HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops +1 more, Substantially Equivalent on 2026-03-18. Applicant: O&M Halyard, Inc.. Device class: 2.

Summary

O&M Halyard's record covers two HALYARD FLUIDSHIELD 3 Fog-Free Procedure Masks with SO SOFT Lining and SO SOFT Earloops, one of them with a WrapAround Visor. (The record's name puts an asterisk after HALYARD, FLUIDSHIELD and each SO SOFT.) They're filed under FXX, surgical masks.

Class II, 21 CFR 878.4040. The General Hospital review panel handled it as a Traditional 510(k), though the record lists General and Plastic Surgery as the classification panel.

O&M Halyard filed from Alpharetta, Georgia. Review took 265 calendar days (June 26, 2025 to March 18, 2026).

Clearance details

Device name as filed
HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround Visor
Applicant
O&M Halyard, Inc.
Product code
Product code FXX
Device class
Class 2
Regulation
21 CFR 878.4040
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Alpharetta, GA, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code FXX

view all

More clearances from O&M Halyard, Inc.

view all

Adverse events under product code FXX

product code FXX
Injury
137
Total
137

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.