SafeSource Direct Blue Powder-Free Nitrile Exam Gloves— 510(k) K222898

Substantially Equivalent

Safesource Direct, LLC

FDA 510(k) clearance K222898 for SafeSource Direct Blue Powder-Free Nitrile Exam Gloves, Substantially Equivalent on 2022-11-07. Applicant: Safesource Direct, LLC.

Clearance details

Applicant
Safesource Direct, LLC
Product code
Code LZA
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Broussard, LA, US
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.