K232777

FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender (25868); FLUIDSHIELD* 1 FogFree Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender, Wrap Around Visor (41798)

510(k) number: K232777
Device name: FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender (25868); FLUIDSHIELD* 1 FogFree Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender, Wrap Around Visor (41798)
Applicant: Owens & Minor (O&M) Halyard, Inc. VA · US
Product code: FXX — Mask, Surgical
Decision date: 2024-07-01
Date received: 2023-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: General, Plastic Surgery

PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain

Also available from FDA: K232777.pdf

Official FDA record: K232777

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