K240545
- 510(k) number
- K240545
- Device name
- GenaCheck Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS/S/M/L/XL)
- Applicant
- Genabio Diagnostics, Inc. MA · US
- Product code
- LZA — Polymer Patient Examination Glove
- Decision date
- 2024-08-28
- Date received
- 2024-02-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K240545.pdf
Official FDA record: K240545
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.