FDA refusals of examination gloves appear to have leveled off as none of the three major types of disposable examination gloves experienced a major increase or decrease from the previous month.
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Archive for the ‘Regulatory Compliance’
Following a record number of container refusals this summer, FDA examination glove refusals sank to six month lows in September. Latex glove refusals continued an upward trend in August climbing to 12-month highs before plummeting in September. Vinyl and nitrile refusals remained relatively stable over the same period of time.
As of October 2009
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Q: What law requires the use of disposable gloves in health care and nursing? -Karen from Texas A&M University, Corpus Christi
A: 29 CFR 1910.1030 requires that gloves be worn “when it can be reasonably anticipated that the employee may have hand contact with blood, other potentially infectious materials, mucous membranes, and non-intact skin; when performing vascular access procedures; and when handling or touching contaminated items or surfaces”.
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Q: Does OSHA require the employer to furnish gloves for employees? -Pam from Evers & Sons via our GloveUniversity.com Ask a Question page.
A: According to 29 CFR 1910.132, employers are required to provide employees protective equipment (including hand protection) at no cost to employees, excluding some specialty foot and eyewear, everyday clothing, or clothing used solely for protection from weather. The employer must also pay for replacement personal protective equipment, except when the employee has lost or intentionally damaged the equipment.
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The number of containers of medical gloves refused by the FDA declined in July after surging to record highs in June. Latex refusals reached a 12-month high in June before retreating slightly in July. Vinyl glove refusals continued an up-and-down pattern, approaching records in June before scaling back in July. Nitrile refusals remained far below record highs set in November 2008.
Glove containers typically hold more than 2.5 million disposable gloves, resulting in potential market shortages when refusals peak unexpectedly.
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