(235 days)
This single use sterile equipment cover is intended for use by professionals in a sterile clinical setting to cover and prevent contamination of non-patient contact equipment during various procedures.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding the "RadScan Equipment Slicker®". This type of document determines substantial equivalence to a predicate device and approves the device for market. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert reviews as requested in your prompt. These details would typically be found in the manufacturer's submission to the FDA, which is not included here.
Therefore, I cannot provide the requested information based on the given document.
§ 878.4370 Surgical drape and drape accessories.
(a)
Identification. A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.(b)
Classification. Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.