K242533
- 510(k) number
- K242533
- Device name
- Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
- Applicant
- Better Care Plastic Technology Co., Ltd. CN
- Product code
- LZA — Polymer Patient Examination Glove
- Decision date
- 2025-03-18
- Date received
- 2024-08-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 1.4 MB · U.S. public domain
Also available from FDA: K242533.pdf
Official FDA record: K242533
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.