K252830
- 510(k) number
- K252830
- Device name
- Disposable Surgical Face Mask (3P00B, C2900)
- Applicant
- Beatles Medical Supplies (Xiantao) Co., Ltd. CN
- Product code
- FXX — Mask, Surgical
- Decision date
- 2026-01-12
- Date received
- 2025-09-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain
Also available from FDA: K252830.pdf
Official FDA record: K252830
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.