Nitrile Examination Gloves (Powder free, Blue)— 510(k) K213029

Substantially Equivalent

Weihai Hongyu Nonwoven Fabric Products Co., Ltd.

FDA 510(k) clearance K213029 for Nitrile Examination Gloves (Powder free, Blue), Substantially Equivalent on 2021-12-14. Applicant: Weihai Hongyu Nonwoven Fabric Products Co., Ltd..

Clearance details

Applicant: Weihai Hongyu Nonwoven Fabric Products Co., Ltd.
Product code: Code LZA
Advisory panel: General Hospital
Date received: 2021-09-21
Decision date: 2021-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Weihai, CN

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.