K233405
- 510(k) number
- K233405
- Device name
- Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl Test Claim
- Applicant
- Eco Medi Glove Sdn. Bhd. MY
- Product code
- LZA — Polymer Patient Examination Glove
- Decision date
- 2023-12-28
- Date received
- 2023-10-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K233405.pdf
Official FDA record: K233405
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.