K230662
- 510(k) number
- K230662
- Device name
- Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select Other Drugs
- Applicant
- Zhonghong Pulin Medical Products Co., Ltd. CN
- Product code
- LZA — Polymer Patient Examination Glove
- Decision date
- 2023-10-26
- Date received
- 2023-03-10
- 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: K230662.pdf
Official FDA record: K230662
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.