Powder Free Blue Nitrile Examination Glove— 510(k) K153732

Substantially Equivalent

Qube Medical Product Sdn Bhd

FDA 510(k) clearance K153732 for Powder Free Blue Nitrile Examination Glove, Substantially Equivalent on 2016-07-29. Applicant: Qube Medical Product Sdn Bhd.

Clearance details

Applicant
Qube Medical Product Sdn Bhd
Product code
Code LZA
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Rawang, 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.