K243133
- 510(k) number
- K243133
- Device name
- Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid
- Applicant
- Kl-Kepong Rubber Products Sdn. Bhd. MY
- Product code
- LZA — Polymer Patient Examination Glove
- Decision date
- 2025-06-17
- Date received
- 2024-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 1.3 MB · U.S. public domain
Also available from FDA: K243133.pdf
Official FDA record: K243133
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.