Latex Examination Powder Free Glove, Aloe Vera— 510(k) K193150

Substantially Equivalent

Top Glove Sdn. Bhd.

FDA 510(k) clearance K193150 for Latex Examination Powder Free Glove, Aloe Vera, Substantially Equivalent on 2020-06-05. Applicant: Top Glove Sdn. Bhd..

Clearance details

Applicant
Top Glove 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.