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Radians
Radians, Inc. · Model RWG9114 · UDI-DI 00674326398655
10
510(k) clearances
78
Adverse events
8
Recalls
276
Facilities
Description
Powder Free Latex Examination Gloves, Blue, Non Sterile. 14 Mil. Extended Cuff. Finger Textured Grip. Single Use. Size Small. Tested for Use with Chemotherapy Drugs per ASTM D6978
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-13 | O&M HALYARD INC | Nitrile Exam Glove failed to meet specifications chemical permeation performance. |
| 2024-05-13 | SVS LLC | Firm received complaints regarding skin irritation when using the gloves, disintegration of the gloves when used with certain cleaning solutions, and mislabeled products (e.g., out |
| 2021-09-27 | O&M HALYARD INC | All lots of the glove may discolor and lose elasticity upon aging, resulting in the inability of the user to don the gloves without tearing. |
| 2011-08-04 | Ansell Healthcare Products LLC | Gloves were inadvertently released for distribution prior to completion of testing required by the U.S. Food and Drug Administration. |
| 2011-08-04 | Ansell Healthcare Products LLC | Gloves were inadvertently released for distribution prior to completion of testing required by the U.S. Food and Drug Administration. |
| 2011-08-04 | Ansell Healthcare Products LLC | Gloves were inadvertently released for distribution prior to completion of testing required by the U.S. Food and Drug Administration. |
| 2011-08-04 | Ansell Healthcare Products LLC | Gloves were inadvertently released for distribution prior to completion of testing required by the U.S. Food and Drug Administration. |
| 2008-07-07 | Integra Pain Management | Radiation reduction gloves were labeled as "Latex-free", but contain natural rubber latex. |
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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.