Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869); Fluidshield* 1 Surgical Mask with SO SOFT* Lining (28802)— 510(k) K232807

Substantially Equivalent

Owens & Minor (O&M) Halyard, Inc.

FDA 510(k) clearance K232807 for Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869); Fluidshield* 1 Surgical Mask with SO SOFT* Lining (28802), Substantially Equivalent on 2024-06-21. Applicant: Owens & Minor (O&M) Halyard, Inc..

Clearance details

Applicant: Owens & Minor (O&M) Halyard, Inc.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2023-09-12
Decision date: 2024-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mechanicsville, VA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FXX

product code FXX

Injury: 137
Total: 137

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.