K231365
- 510(k) number
- K231365
- Device name
- Nitrile Patient Examination Gloves with Hyaluronic Acid Blue Colored and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, aka Synguard C+ Nitrile Exam Gloves
- Applicant
- Anhui Intco Medical Products Co., Ltd. CN
- Product code
- LZA — Polymer Patient Examination Glove
- Decision date
- 2024-03-01
- Date received
- 2023-05-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K231365.pdf
Official FDA record: K231365
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.