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Radians
Radians, Inc. · Model RWG9114 · UDI-DI 00674326398679
10
510(k) clearances
2,995
Adverse events (17 deaths)
6
Recalls
150
Facilities
Description
Powder Free Latex Examination Gloves, Blue, Non Sterile. 14 Mil. Extended Cuff. Finger Textured Grip. Single Use. Size Large. Tested for Use with Chemotherapy Drugs per ASTM D6978
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.