EONS Nitrile Examination Gloves Powder Free— 510(k) K213286

Substantially Equivalent

Eons Gloves (Thailand) Co., Ltd.

FDA 510(k) clearance K213286 for EONS Nitrile Examination Gloves Powder Free, Substantially Equivalent on 2022-02-19. Applicant: Eons Gloves (Thailand) Co., Ltd..

Clearance details

Applicant: Eons Gloves (Thailand) Co., Ltd.
Product code: Code LZA
Advisory panel: General Hospital
Date received: 2021-10-01
Decision date: 2022-02-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Phra Samut Chedi, TH

Download summary PDF View on FDA.gov ↗

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.