(132 days)
Medline Gore Panel Coverage Surgical Gowns and Gore Critical Coverage Surgical Gowns are surgical apparel that are intended to be worn by operating room personnel during surgical procedures to protect both the patient and the operating room personnel from transfer of micro organisms, and particulate material. The surgical gowns are available in styles with non-Gore-Tex panels comprised of a 100% polyester material.
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This document is a 510(k) clearance letter from the FDA for a medical device: "Gore-Tex Non-Sterile Surgical Gowns" manufactured by Medline Industries. This type of document does not contain the information requested in your prompt (acceptance criteria, study details, sample sizes, ground truth information, MRMC studies, or standalone performance).
The 510(k) clearance process focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than requiring new clinical studies to prove effectiveness or safety by meeting specific performance criteria.
Therefore, I cannot provide the requested information based solely on the provided text.
§ 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.