Disposible Nitrile Gloves— 510(k) K223280

Substantially Equivalent

Holik Asia Group Co.,Ltd

FDA 510(k) clearance K223280 for Disposible Nitrile Gloves, Substantially Equivalent on 2023-05-08. Applicant: Holik Asia Group Co.,Ltd.

Clearance details

Applicant
Holik Asia Group Co.,Ltd
Product code
Code LZA
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Xuancheng, 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.