K232824

FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White (41802); FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White, Wrap Around Visor (41803); FLUIDSHIELD* 1 Surgical Mask with SO SOFT* Lining, White, (41805)

510(k) number: K232824
Device name: FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White (41802); FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White, Wrap Around Visor (41803); FLUIDSHIELD* 1 Surgical Mask with SO SOFT* Lining, White, (41805)
Applicant: Owens & Minor (O&M) Halyard, Inc. VA · US
Product code: FXX — Mask, Surgical
Decision date: 2024-07-02
Date received: 2023-09-13
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: General, Plastic Surgery

PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain

Also available from FDA: K232824.pdf

Official FDA record: K232824

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