CLEANTEXX POWDERFREE SYNTHETIC LATEX EXAMINATION GLOVE MADE WITH BARRIER-PRO BUTADIENE CO-POLMER— 510(k) K013303

Substantially Equivalent

Latexx Manufacturing Sdn.Bhd.

FDA 510(k) clearance K013303 for CLEANTEXX POWDERFREE SYNTHETIC LATEX EXAMINATION GLOVE MADE WITH BARRIER-PRO BUTADIENE CO-POLMER, Substantially Equivalent on 2002-01-23. Applicant: Latexx Manufacturing Sdn.Bhd..

Clearance details

Applicant
Latexx Manufacturing Sdn.Bhd.
Product code
Code LZA
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Taiping, Perak, 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.