K222815

Substantially Equivalent

Powder Free Nitrile Examination Gloves (Blue, White and Black), Tested For Use With Chemotherapy Drugs and Fentanyl

Applicant: Zibo Lanhua Medical Packaging Material Co., Ltd.
Product code: LZA
Advisory panel: General Hospital
Date received: 2022-09-19
Decision date: 2022-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zibo, CN

Adverse events under product code LZA

product code LZA

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.