Nitrile Glove Powder Free Blue— 510(k) K210145

Substantially Equivalent

Changzhou Universal Medical Equipment Co., Ltd.

FDA 510(k) clearance K210145 for Nitrile Glove Powder Free Blue, Substantially Equivalent on 2021-04-21. Applicant: Changzhou Universal Medical Equipment Co., Ltd..

Clearance details

Applicant
Changzhou Universal Medical Equipment Co., Ltd.
Product code
Code LZA
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Xinbei District, 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.