DYNAREX/TILLOTSON NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAM GLOVE FOR USE WITH CHEMOTHERAPY DRUGS— 510(k) K081569

Substantially Equivalent

Dynarex Corporation

FDA 510(k) clearance K081569 for DYNAREX/TILLOTSON NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAM GLOVE FOR USE WITH CHEMOTHERAPY DRUGS, Substantially Equivalent on 2008-09-12. Applicant: Dynarex Corporation. Device class: 1.

Clearance details

Applicant
Dynarex Corporation
Product code
Code LZA
Device class
Class 1
Regulation
21 CFR 880.6250
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Abbreviated
Location
Orangeburg, NY, US
Download summary PDFView on FDA.gov ↗

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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.