K232319
- 510(k) number
- K232319
- Device name
- Black Pearl Nitrile Examination Glove
- Applicant
- Ug Global Resources Sdn. Bhd. MY
- Product code
- LZA — Polymer Patient Examination Glove
- Decision date
- 2024-04-22
- Date received
- 2023-08-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K232319.pdf
Official FDA record: K232319
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.