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NitriTech Ultra
SUMMIT GLOVE INC. · Model 61040PF-L · UDI-DI 00850020255986
10
510(k) clearances
706
Adverse events
10
Recalls
383
Facilities
Description
6mil, 12" in Length, Nitrile, Examination Grade, Ambidextrous, Powder Free, Microtextured Finish, Single Use, Beaded Cuff, Blue, Size Large
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-14 | American Nitrile Operations Llc | Gloves may exhibit defects such as tears, missing fingers, and debris. Use of defective gloves may lead to healthcare personnel and patient exposure to infectious pathogens leading |
| 2026-08-14 | American Nitrile Operations Llc | Gloves may exhibit defects such as tears, missing fingers, and debris. Use of defective gloves may lead to healthcare personnel and patient exposure to infectious pathogens leading |
| 2026-08-14 | American Nitrile Operations Llc | Gloves may exhibit defects such as tears, missing fingers, and debris. Use of defective gloves may lead to healthcare personnel and patient exposure to infectious pathogens leading |
| 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.