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As of January 18, 2017, the Food and Drug Administration (FDA) has imposed a ban on all medical-grade powdered disposable gloves. This decisive ruling, enacted on December 19, 2016, is a response to the FDA’s determination that powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s glove pose an unreasonable and substantial risk of illness or injury. This risk, deemed uncorrectable or uneliminable through labeling or a change in labeling, prompted the agency to take this impactful step.
The ban encompasses existing goods already in commercial distribution or sold to end-users and extends to those slated for future sale or distribution. It’s essential to note that the prohibition does not extend to non-powdered versions of surgeon’s gloves and patient examination gloves. Additionally, exemptions include powder used in the manufacturing process of non-powdered gloves, provided that the powder is not intended to be part of the final finished gloves. Similarly, powder intended for use in or on other medical devices is not subject to this ban.
For those seeking disposable gloves, we offer a comprehensive selection to meet your needs. Whether you require non-powdered surgeon’s gloves, patient examination gloves, or other disposable glove options, we have you covered. Our commitment to quality and compliance ensures that you receive gloves that adhere to the latest FDA regulations, guaranteeing the safety of both users and patients.
To explore our range of disposable gloves or discuss your specific requirements, don’t hesitate to get in touch with us. We understand the importance of maintaining high standards in healthcare, and our team is ready to assist you in finding the right glove solutions.
For more detailed information, you can refer to the full text from the Federal Register at https://www.regulations.gov/document?D=FDA-2015-N-5017-0173.
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