K233598
- 510(k) number
- K233598
- Device name
- Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs
- Applicant
- Anhui Intco Medical Products Co., Ltd. CN
- Product code
- LZA — Polymer Patient Examination Glove
- Decision date
- 2024-01-26
- Date received
- 2023-11-09
- 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: K233598.pdf
Official FDA record: K233598
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.