K250342
- 510(k) number
- K250342
- Device name
- Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl
- Applicant
- Encompass Industries Sdn. Bhd. MY
- Product code
- LZA — Polymer Patient Examination Glove
- Decision date
- 2025-07-08
- Date received
- 2025-02-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K250342.pdf
Official FDA record: K250342
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.