K252075
- 510(k) number
- K252075
- Device name
- Program insite® Powder-Free, Disposable Nitrile Exam Gloves
- Applicant
- Program Insite, LLC MD · US
- Product code
- LZA — Polymer Patient Examination Glove
- Decision date
- 2025-10-17
- Date received
- 2025-07-02
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K252075.pdf
Official FDA record: K252075
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.