Powder Free Blue Nitrile Examination Gloves— 510(k) K213678

Substantially Equivalent

Lienteh Technology Sdn Bhd

FDA 510(k) clearance K213678 for Powder Free Blue Nitrile Examination Gloves, Substantially Equivalent on 2022-03-22. Applicant: Lienteh Technology Sdn Bhd.

Clearance details

Applicant
Lienteh Technology Sdn Bhd
Product code
Code LZA
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Klang, MY
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.