K233990
- 510(k) number
- K233990
- Device name
- Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000)
- Applicant
- Shandong Xingyu Gloves Co., Ltd. CN
- Product code
- LZA — Polymer Patient Examination Glove
- Decision date
- 2024-04-01
- Date received
- 2023-12-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K233990.pdf
Official FDA record: K233990
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.