K232444
- 510(k) number
- K232444
- Device name
- Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs
- Applicant
- Grand Work Plastic Products Co., Ltd. CN
- Product code
- KGO — Surgeon'S Gloves
- Decision date
- 2023-12-20
- Date received
- 2023-08-14
- 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: K232444.pdf
Official FDA record: K232444
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.