(91 days)
The Bouffant Cap is a device intended to be worn by hospital personnel during procedures to protect both the patient and the hospital personnel from transfer of microorganisms, body fluids and particulate materials.
Bouffant Cap
The provided text is a letter from the FDA regarding the clearance of a "Bouffant Cap" device. It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.
Therefore, I cannot fulfill the request using the provided input. The document is a regulatory approval letter, not a scientific study report.
§ 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.