K241909
- 510(k) number
- K241909
- Device name
- Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid
- Applicant
- O&M Halyard, Inc. VA · US
- Product code
- LZA — Polymer Patient Examination Glove
- Decision date
- 2024-09-27
- Date received
- 2024-07-01
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K241909.pdf
Official FDA record: K241909
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.