K243441
- 510(k) number
- K243441
- Device name
- Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (Light blue, Dark blue)
- Applicant
- Basic Medical Technology, Inc. CA · US
- Product code
- LZA — Polymer Patient Examination Glove
- Decision date
- 2025-01-31
- Date received
- 2024-11-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 1.7 MB · U.S. public domain
Also available from FDA: K243441.pdf
Official FDA record: K243441
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.