K231446
- 510(k) number
- K231446
- Device name
- Single-Use Latex Sterile Surgical Gloves (SG100)
- Applicant
- Fitone Latex Products Co., Ltd. Guangdong CN
- Product code
- KGO — Surgeon'S Gloves
- Decision date
- 2023-09-22
- Date received
- 2023-05-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K231446.pdf
Official FDA record: K231446
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.