(566 days)
Medline Disposable Surgical Drapes are surgical apparel that are intended to be worn by Meditie Disposative Burgical procedures to protect both the surgical patient and the operating room personnel from transfer of body fluids, micro-organisms, and particulate material.
Medline Disposable Surgical Drapes are intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.
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I am sorry, but the provided text does not contain information about the acceptance criteria and study that proves a device meets those criteria. The document is a 510(k) premarket notification letter from the FDA to Medline Industries regarding their surgical gowns and drapes. It discusses the substantial equivalence of these devices to legally marketed predicate devices and outlines regulatory responsibilities. It does not include details about specific performance studies, acceptance criteria, or ground truth establishment.
§ 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.