K233068
- 510(k) number
- K233068
- Device name
- Disposable Surgical Gown
- Applicant
- Nanning Tecbod Biological Technology Co., Ltd. CN
- Product code
- FYA — Gown, Surgical
- Decision date
- 2024-03-29
- Date received
- 2023-09-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K233068
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.