K232894

HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining (39123), HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining and Visor (39124)

510(k) number: K232894
Device name: HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining (39123), HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining and Visor (39124)
Applicant: Owens & Minor (O&M) Halyard, Inc. VA · US
Product code: FXX — Mask, Surgical
Decision date: 2024-01-08
Date received: 2023-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: General, Plastic Surgery

PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain

Also available from FDA: K232894.pdf

Official FDA record: K232894

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.