K232550
- 510(k) number
- K232550
- Device name
- Nitrile Examination Gloves, Dual Color Black-Blue
- Applicant
- Shanxi Hongjin Plastic Technology Co., Ltd. CN
- Product code
- LZA — Polymer Patient Examination Glove
- Decision date
- 2023-10-20
- Date received
- 2023-08-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K232550.pdf
Official FDA record: K232550
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.