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ESP

BOSTON SCIENTIFIC CORPORATION · Model M0067051030 · UDI-DI 08714729752899

LZC Prescription
10
510(k) clearances
78
Adverse events
8
Recalls
276
Facilities

Description

Radiation Reduction Examination Gloves

Recalls

DateFirmReason
2026-04-13O&M HALYARD INCNitrile Exam Glove failed to meet specifications chemical permeation performance.
2024-05-13SVS LLCFirm 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
2021-09-27O&M HALYARD INCAll lots of the glove may discolor and lose elasticity upon aging, resulting in the inability of the user to don the gloves without tearing.
2011-08-04Ansell Healthcare Products LLCGloves were inadvertently released for distribution prior to completion of testing required by the U.S. Food and Drug Administration.
2011-08-04Ansell Healthcare Products LLCGloves were inadvertently released for distribution prior to completion of testing required by the U.S. Food and Drug Administration.
2011-08-04Ansell Healthcare Products LLCGloves were inadvertently released for distribution prior to completion of testing required by the U.S. Food and Drug Administration.
2011-08-04Ansell Healthcare Products LLCGloves were inadvertently released for distribution prior to completion of testing required by the U.S. Food and Drug Administration.
2008-07-07Integra Pain ManagementRadiation reduction gloves were labeled as "Latex-free", but contain natural rubber latex.

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Data 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.