K242937
- 510(k) number
- K242937
- Device name
- Dream Medi Sterile Surgical Gown (SurgicalGownUL)
- Applicant
- Dae Myung Chemical Co., Ltd. (Vietnam) VN
- Product code
- FYA — Gown, Surgical
- Decision date
- 2025-05-05
- Date received
- 2024-09-25
- 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: K242937.pdf
Official FDA record: K242937
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.