K243010
- 510(k) number
- K243010
- Device name
- Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804); Fluidshield * 3 Surgical Mask with SO SOFT* Lining (48208); Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining (48207); Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining, with Visor (48237); Fluidshield* 3 Fog-Free Surgical Mask with SO SOFT* Lining, Anti-Glare WrapAround Visor (48247); Fluidshield * 3 Fog-Free Procedure Mask with SO SOFT* Earloops (28797); Fluidshield * 3 Fog-Free Proce
- Applicant
- Owens & Minor (O&M) Halyard, Inc. VA · US
- Product code
- FXX — Mask, Surgical
- Decision date
- 2025-05-30
- Date received
- 2024-09-26
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K243010.pdf
Official FDA record: K243010
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.