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NitriDerm® Ultra Orange™
INNOVATIVE HEALTHCARE CORPORATION · Model SPK199 · UDI-DI 00813172024909
10
510(k) clearances
635
Adverse events
7
Recalls
380
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-10-23 | HUBO INTERNATIONAL INC | Package labeled as nitrile gloves, contains latex gloves. |
| 2019-03-22 | Cardinal Health 200, LLC | Kit label states not made with natural rubber latex,however safety goggles within the kits contain natural rubber latex in the goggle strap |
| 2019-03-22 | Cardinal Health 200, LLC | Kit label states not made with natural rubber latex,however safety goggles within the kits contain natural rubber latex in the goggle strap |
| 2019-03-22 | Cardinal Health 200, LLC | Kit label states not made with natural rubber latex,however safety goggles within the kits contain natural rubber latex in the goggle strap |
| 2019-03-22 | Cardinal Health 200, LLC | Kit label states not made with natural rubber latex,however safety goggles within the kits contain natural rubber latex in the goggle strap |
| 2016-11-10 | Halyard Health | Defects: Product may be discolored and brittle resulting in the inability of the user to don the gloves without tearing. |
| 2015-08-25 | Cardinal Health | Ambitex Nitrile NMD400 Exam Gloves size medium on exam hold were inadvertently placed into commerce. The product was under Exam Hold because samples pulled from a shipment manufact |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.