Disposable Medical Nitrile Examination Gloves (Model:XYS-001)— 510(k) K213371

Substantially Equivalent

Anhui Xinyisheng Medical Technology Co.,Ltd

FDA 510(k) clearance K213371 for Disposable Medical Nitrile Examination Gloves (Model:XYS-001), Substantially Equivalent on 2021-12-09. Applicant: Anhui Xinyisheng Medical Technology Co.,Ltd.

Clearance details

Applicant
Anhui Xinyisheng Medical Technology Co.,Ltd
Product code
Code LZA
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Suzhou, 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.