K240080
- 510(k) number
- K240080
- Device name
- Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
- Applicant
- Syntex Healthcare Products Co., Ltd. CN
- Product code
- LZA — Polymer Patient Examination Glove
- Decision date
- 2024-04-02
- Date received
- 2024-01-11
- 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: K240080.pdf
Official FDA record: K240080
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.