510(k) K252244— Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, Xylazine, Gastric acid, Fentanyl in Gastric acid and Xylazine in Gastric acid

Substantially Equivalent

Ever Global (Vietnam) Enterprise Corporation

Clearance details

Applicant: Ever Global (Vietnam) Enterprise Corporation
Product code: Code LZA
Advisory panel: General Hospital
Date received: 2025-07-18
Decision date: 2025-08-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Taman Village, VN

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.