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AMBITEX
Tradex International, Inc. · Model LXL800 · UDI-DI 00699320102152
10
510(k) clearances
2,992
Adverse events (17 deaths)
6
Recalls
150
Facilities
Description
AMBITEX GLV EXAM NON-STERILE LATEX DURASILK L800 CREAM POWDER-FREE EXTRA LARGE FINGER TEXTURED STANDARD LENGTH 10/100
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-08-19 | Ansell Healthcare Products LLC | Examination gloves were shipped inadvertently, without to verify barrier integrity. |
| 2011-12-22 | Adenna Inc | The recall was initiated because Adenna Inc. distributed latex gloves that have been FDA refused. |
| 2006-04-10 | Gulf South Medical Supply Inc | FDA's laboratory analysis found holes in the gloves that exceeded the allowable limit. Gloves with holes compromise the integrity of the latex barrier and have the potential to all |
| 2003-06-27 | Henry Schein, Inc. | FDA's analysis revealed defects (holes) in the latex gloves. |
| 2003-06-27 | Henry Schein, Inc. | FDA's analysis revealed defects (holes) in the latex gloves. |
| 2002-07-23 | American Healthcare Products Inc | Unfit for intended use due to stickiness. |
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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.