(115 days)
The surgeon's gloves is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
SENSIFLEX PLUS Sterile Latex Green Surgical Glove Powder Free with Protein Content Labeling Claim with 50ug/dm2 or less
The provided document is a 510(k) clearance letter from the FDA for a surgical glove. It does not contain information about the acceptance criteria or a study proving that an AI/Software as a Medical Device (SaMD) meets such criteria. The document is for a physical medical device (surgical gloves) and thus the requested information, which pertains to AI/SaMD, is not applicable.
Therefore, I cannot extract the requested information from this document.
§ 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).