K232070
- 510(k) number
- K232070
- Device name
- Biodegradable Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black, Green)
- Applicant
- Better Care Plastic Technology Co., Ltd. CN
- Product code
- LZA — Polymer Patient Examination Glove
- Decision date
- 2023-10-11
- Date received
- 2023-07-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K232070.pdf
Official FDA record: K232070
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.