K233022
- 510(k) number
- K233022
- Device name
- Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 2 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, White, Regular and Small
- Applicant
- Owens & Minor (O&M) Halyard, Inc. VA · US
- Product code
- MSH — Respirator, Surgical
- Decision date
- 2024-01-12
- Date received
- 2023-09-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K233022.pdf
Official FDA record: K233022
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.