Nitrile Powder-Free Exam Gloves 2.8, Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (light blue, dark blue)— 510(k) K250193

Substantially Equivalent

Basic Medical Technology, Inc.

FDA 510(k) clearance K250193 for Nitrile Powder-Free Exam Gloves 2.8, Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (light blue, dark blue), Substantially Equivalent on 2025-07-09. Applicant: Basic Medical Technology, Inc..

Clearance details

Applicant
Basic Medical Technology, Inc.
Product code
Code LZA
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Ontario, CA, 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.