(154 days)
The Polyisoprene Surgical Gloves are single use device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. It is provided sterile.
Polyisoprene Surgical gloves
I am sorry, but the provided text from the FDA document (K240790) pertains to the clearance of "Polyisoprene Surgical gloves" and focuses entirely on regulatory information, such as:
- The FDA's decision regarding the 510(k) premarket notification.
- Classification of the device (Class I, reserved).
- Applicable regulations (e.g., 21 CFR 878.4460 for Non-Powdered Surgeon's Glove, Quality System regulation 21 CFR Part 820).
- Guidance on changes requiring new premarket notifications.
- Information on adverse event reporting and other regulatory compliance.
- The "Indications for Use" for the surgical gloves.
This document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any details related to AI/algorithm-based medical devices. It is a regulatory clearance letter for a non-software/AI medical device.
Therefore, I cannot provide the requested information regarding acceptance criteria and study details based on the provided text.
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls).