USA – Proposing banned on different types of gloves used in surgery

To Protect of human health or safety, Food and Drug Administration (FDA), Health and Human Services (HHS) has issued notification pertains to Powdered gloves. Medical  equipment.

The Food and Drug Administration (FDA or Agency) has determined that Powdered Surgeon's Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Glove present an unreasonable and substantial risk of illness or injury and that the risk cannot be corrected or eliminated by labeling or a change in labeling. Consequently, FDA is proposing these devices be banned.

Proposed date of adoption: To be determined

Proposed date of entry into force: To be determined

Final date for comments: 20 June 2016

If the Proposal/Notification/Regulation will affect your International Business please send us your representation with facts and figures, so that these can be taken up suitably.