K232654
- 510(k) number
- K232654
- Device name
- Nephron Nitrile, Nitrile Powder-Free Examination Gloves Black (Tested For Use With Chemotherapy Drugs and Fentanyl)
- Applicant
- Nephron Nitrile, LLC SC · US
- Product code
- LZA — Polymer Patient Examination Glove
- Decision date
- 2024-03-20
- Date received
- 2023-08-31
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General Hospital
510(k) Summary (official FDA PDF): K232654.pdf
Official FDA record: K232654
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.