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The Polyisoprene Powder Free Surgical Glove is a disposable device that is intended to be worn the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminations.
The Polyisoprene Powder Free Surgical Underglove is a disposable device that is intended to be worn the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminations.

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The provided document is a 510(k) premarket notification letter from the FDA regarding surgical gloves and undergloves, and it does not contain the information required to answer the prompt.

The document discusses:

• The FDA's review and determination of substantial equivalence for two medical devices: "Polyisoprene Powder Free Surgical Underglove" and "Polyisoprene Powder Free Surgical Glove."
• General regulatory requirements for medical devices, such as annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
• Indications for Use for both devices, stating they are disposable devices intended to be worn on hands in surgical settings to provide a barrier against potentially infectious materials and other contaminations.
• That both devices are for "Over-The-Counter Use."

The document does not include:

• A table of acceptance criteria and reported device performance.
• Information about sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, types of ground truth, or details about training sets.

Therefore, I cannot provide the requested details based on the given input.

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