O'Star Nitrile Examination Gloves Powder Free— 510(k) K213058

Substantially Equivalent

Star Investment and Trade Joint Stock Company

FDA 510(k) clearance K213058 for O'Star Nitrile Examination Gloves Powder Free, Substantially Equivalent on 2022-02-08. Applicant: Star Investment and Trade Joint Stock Company.

Clearance details

Applicant
Star Investment and Trade Joint Stock Company
Product code
Code LZA
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Bac Ninh, VN
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.