K250578
- 510(k) number
- K250578
- Device name
- Nitrile Examination Gloves Powder Free Tested for Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black)
- Applicant
- Careglove Global Sdn. Bhd. MY
- Product code
- LZA — Polymer Patient Examination Glove
- Decision date
- 2025-04-01
- Date received
- 2025-02-27
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K250578.pdf
Official FDA record: K250578
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.