Nitrile Examination Gloves— 510(k) K213044

Substantially Equivalent

Jiangsu Huayuan Medical Technology Co., Ltd.

FDA 510(k) clearance K213044 for Nitrile Examination Gloves, Substantially Equivalent on 2022-01-21. Applicant: Jiangsu Huayuan Medical Technology Co., Ltd..

Clearance details

Applicant
Jiangsu Huayuan Medical Technology Co., Ltd.
Product code
Code LZA
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Dongtai City, CN
Download summary PDFView on FDA.gov ↗

Adverse events under product code LZA

product code LZA
Other
1
Total
1

Source: openFDA MAUDE database, through . 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.