K253160
- 510(k) number
- K253160
- Device name
- Syntex Exam Gloves
- Applicant
- Basic Medical Technology, Inc. CA · US
- Product code
- LZA — Polymer Patient Examination Glove
- Decision date
- 2026-01-23
- Date received
- 2025-09-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K253160.pdf
Official FDA record: K253160
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.