K232112
- 510(k) number
- K232112
- Device name
- R&G Surgical Mask
- Applicant
- R&G Seguridad E Higiene Industrial S.A.C. PE
- Product code
- FXX — Mask, Surgical
- Decision date
- 2024-04-02
- Date received
- 2023-07-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 1.4 MB · U.S. public domain
Also available from FDA: K232112.pdf
Official FDA record: K232112
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.