K251716
- 510(k) number
- K251716
- Device name
- Nitrile Powder-Free Exam Gloves 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
- 2025-08-27
- Date received
- 2025-06-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 1.3 MB · U.S. public domain
Also available from FDA: K251716.pdf
Official FDA record: K251716
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.