K240361
- 510(k) number
- K240361
- Device name
- Powder Free Green Nitrile Examination Gloves (XS/S/M/L/XL); Powder Free Pink Nitrile Examination Gloves (XS/S/M/L/XL); Powder Free Purple Nitrile Examination Gloves (XS/S/M/L/XL)
- Applicant
- Hebei Titans Hongsen Medical Technology Co., Ltd. CN
- Product code
- LZA — Polymer Patient Examination Glove
- Decision date
- 2024-04-04
- Date received
- 2024-02-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K240361.pdf
Official FDA record: K240361
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.