K230777
- 510(k) number
- K230777
- Device name
- Patient Examination Gloves
- Applicant
- 3A Glove Sdn. Bhd. MY
- Product code
- LZA — Polymer Patient Examination Glove
- Decision date
- 2023-10-06
- Date received
- 2023-03-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K230777.pdf
Official FDA record: K230777
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.