K243604
- 510(k) number
- K243604
- Device name
- Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric Acid
- Applicant
- O&M Halyard, Inc. GA · US
- Product code
- LZA — Polymer Patient Examination Glove
- Decision date
- 2025-08-18
- Date received
- 2024-11-21
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Advisory committee
- General Hospital
510(k) Summary (official FDA PDF): K243604.pdf
Official FDA record: K243604
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.