Disposable Medical Nitrile Gloves— 510(k) K211673

Substantially Equivalent

Changzhou Yihua Sanitation Material Co., Ltd.

FDA 510(k) clearance K211673 for Disposable Medical Nitrile Gloves, Substantially Equivalent on 2021-09-01. Applicant: Changzhou Yihua Sanitation Material Co., Ltd..

Clearance details

Applicant
Changzhou Yihua Sanitation Material Co., Ltd.
Product code
Code LZA
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Changzhou, 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.