K243959
- 510(k) number
- K243959
- Device name
- Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other Drugs
- Applicant
- Lingshi Hongruida Health Protection Technology Co., Ltd. CN
- Product code
- LZC — Medical Glove, Specialty
- Decision date
- 2025-02-24
- Date received
- 2024-12-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K243959.pdf
Official FDA record: K243959
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.