K243818
- 510(k) number
- K243818
- Device name
- Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
- Applicant
- Hartalega NGC Sdn. Bhd. MY
- Product code
- LZA — Polymer Patient Examination Glove
- Decision date
- 2025-01-08
- Date received
- 2024-12-12
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K243818.pdf
Official FDA record: K243818
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.