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Radians
Radians, Inc. · Model RWG9413 · UDI-DI 00674326398822
10
510(k) clearances
80
Adverse events
8
Recalls
277
Facilities
Description
Powder Free Nitrile Examination Gloves, Blue, Non Sterile, Low Dermatitis Potential. 3 Mil. Finger Textured Grip. Single Use. Size Large. Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Gastric Acid 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.