K250630
- 510(k) number
- K250630
- Device name
- Nitrile Powder-Free Exam Gloves with Hyaluronic Acid, and tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate
- Applicant
- Basic Medical Technology, Inc. CA · US
- Product code
- LZA — Polymer Patient Examination Glove
- Decision date
- 2025-05-22
- Date received
- 2025-03-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K250630.pdf
Official FDA record: K250630
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.