K233042
- 510(k) number
- K233042
- Device name
- Sterile Nitrile Examination Gloves Powder Free Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
- Applicant
- Shandong Intco Medical Products Co, Ltd. CN
- Product code
- LZA — Polymer Patient Examination Glove
- Decision date
- 2023-12-06
- Date received
- 2023-09-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
510(k) Summary (official FDA PDF): K233042.pdf
Official FDA record: K233042
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.