K240629
- 510(k) number
- K240629
- Device name
- Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl
- Applicant
- Xingyu Medical Tech Co., Ltd. CN
- Product code
- LZA — Polymer Patient Examination Glove
- Decision date
- 2024-05-28
- Date received
- 2024-03-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K240629.pdf
Official FDA record: K240629
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.