K243694
- 510(k) number
- K243694
- Device name
- Nitrile Powder Free Examination Glove with Tremella Fuciformis Extract, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate - Blue
- Applicant
- Mah Sing Healthcare Sdn. Bhd. MY
- Product code
- LZA — Polymer Patient Examination Glove
- Decision date
- 2025-06-06
- Date received
- 2024-11-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K243694.pdf
Official FDA record: K243694
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.