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Wavy Donning Gloves

SIGVARIS INC · Model 590R · UDI-DI 00745129215293

IKX

510(k) clearances

2,515

Adverse events (25 deaths)

Recalls

281

Facilities

Description

A device made of natural latex intended to assist patients and caregivers in donning and removing compression stockings and garments without causing damage to the stocking (e.g. from nails, jewelry). This device will have appropriate characteristics regarding tactility/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. This is a single-use device.

Recalls

Date	Firm	Reason
2024-11-05	NOA Medical Industries Inc	Red button used to engage side rails can break or become stuck making it difficult to engage the side rail.
2020-09-15	Medline Industries Inc	The buckle on the Gait Belt may break due to degradation of the material due to exposure to gamma radiation.
2017-08-10	Medline Industries Inc	The locking mechanism on the belt may fail to secure/hold the strap when in locked position potentially allowing the belt strap to slip through the buckle.
2017-08-10	Medline Industries Inc	The locking mechanism on the belt may fail to secure/hold the strap when in locked position potentially allowing the belt strap to slip through the buckle.
2017-05-30	EOS Imaging	ROTH MOBELI grab handles could detach and patient could fall if the EOS system operator does not follow instructions. Before each use, the operator must examine the vacuum safety i
2015-03-26	Handicare USA, Inc.	Complaints were received that the heat-welded seam on the wipeable belt's strap tore when force was applied.
2014-04-15	Handicare USA, Inc.	During the period of April 2009 May 2011, Handicare AB used a wing handle in which the screw and handle, after repeated tightening, may slide apart. This causes a small amount of
2012-03-20	North Coast Medical Inc	Due to a consumer complaint, North Coast Medical determined that due to a design flaw, there was not enough plastic support material to retain bracket bolts when subjected to a for
2009-07-09	Nutech Manufacturing Corp	Safety chair used in shower/bath may not meet specifications for weight load.
2009-07-09	Nutech Manufacturing Corp	Safety chair used in shower/bath may not meet specifications for weight load.

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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.