510K - NOT required for Class 1 medical devices - Period.
A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device.
Do Class 1 medical devices need a 510k?
Most Class I devices are exempt from Premarket Notification 510(k); most Class II devices require Premarket Notification 510(k), and most Class III devices require Premarket Approval
The new enforcement policy states that the FDA does not intend to enforce any of the standard premarket requirements you mentioned for these gloves provided that the product labeling does not create undue risk. FDA believes that such devices do not create an undue risk where, for example, the product includes labeling that:
Accurately describes the product as an “unpowdered glove”
Accurately describes its sterility status when individually packaged (non-sterile);
Includes a list of the body contacting materials.
May 14, 2021
April 27, 2021
April 16, 2021
Douglas Stein | PPE Advantage
WhatsApp: +1 (773) 814-0215
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