K230847
- 510(k) number
- K230847
- Device name
- Chemotherapy Gloves
- Applicant
- 3A Glove Sdn. Bhd. MY
- Product code
- LZA — Polymer Patient Examination Glove
- Decision date
- 2023-09-29
- Date received
- 2023-03-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.1 MB · U.S. public domain
Also available from FDA: K230847.pdf
Official FDA record: K230847
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.