K231029
- 510(k) number
- K231029
- Device name
- Nitrile Exam Glove, Tested For Use With Chemotherapy Drugs And Fentanyl
- Applicant
- Zhonghong Pulin Medical Products Co., Ltd. CN
- Product code
- LZA — Polymer Patient Examination Glove
- Decision date
- 2023-10-30
- Date received
- 2023-04-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
510(k) Summary (official FDA PDF): K231029.pdf
Official FDA record: K231029
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.