K250313
- 510(k) number
- K250313
- Device name
- Sterile Powder Free Synthetic Rubber Surgeons Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid
- Applicant
- Harps Europe Manufacturing GmbH AT
- Product code
- KGO — Surgeon'S Gloves
- Decision date
- 2025-08-19
- Date received
- 2025-02-03
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 1.3 MB · U.S. public domain
Also available from FDA: K250313.pdf
Official FDA record: K250313
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.