K250502
- 510(k) number
- K250502
- Device name
- SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (AMERI-TUFF Series 4000, AMERI-TOUCH Series 5000)
- Applicant
- Safesource Direct, LLC LA · US
- Product code
- LZA — Polymer Patient Examination Glove
- Decision date
- 2025-03-19
- Date received
- 2025-02-20
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 1.3 MB · U.S. public domain
Also available from FDA: K250502.pdf
Official FDA record: K250502
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.