K241214
- 510(k) number
- K241214
- Device name
- ProPel SG3 Surgical Gown
- Applicant
- Standard Textile Co., Inc. OH · US
- Product code
- FYA — Gown, Surgical
- Decision date
- 2024-09-10
- Date received
- 2024-04-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K241214.pdf
Official FDA record: K241214
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.