K232064
- 510(k) number
- K232064
- Device name
- Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentanyl Citrate)
- Applicant
- Isikel Manufacturing, LLC TX · US
- Product code
- LZA — Polymer Patient Examination Glove
- Decision date
- 2023-10-02
- Date received
- 2023-07-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 1.4 MB · U.S. public domain
Also available from FDA: K232064.pdf
Official FDA record: K232064
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.