K233520
- 510(k) number
- K233520
- Device name
- Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl
- Applicant
- Anhui Powerguard Technology Co., Ltd. CN
- Product code
- LZA — Polymer Patient Examination Glove
- Decision date
- 2024-01-12
- Date received
- 2023-11-01
- 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: K233520.pdf
Official FDA record: K233520
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.