K233526
- 510(k) number
- K233526
- Device name
- Medline Open-back Level 3 Protective Gown
- Applicant
- Medline Industries, LP IL · US
- Product code
- QPC — Gown, Non-Sterile, Non-Isolation, Intended To Provid
- Decision date
- 2024-03-05
- Date received
- 2023-11-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K233526.pdf
Official FDA record: K233526
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.