K232764
- 510(k) number
- K232764
- Device name
- Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
- Applicant
- Eco Medi Glove Sdn. Bhd. MY
- Product code
- LZA — Polymer Patient Examination Glove
- Decision date
- 2024-02-07
- Date received
- 2023-09-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K232764.pdf
Official FDA record: K232764
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.