K252534
- 510(k) number
- K252534
- Device name
- Surgical Face Mask (Ear mount)
- Applicant
- Zhejiang Hangkang Medical Equipment Co., Ltd. CN
- Product code
- FXX — Mask, Surgical
- Decision date
- 2026-03-03
- Date received
- 2025-08-12
- 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: K252534
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.