(113 days)
The Surgical Gown is intended to be worn by operating room personnel during surgical procedures to protect both the surqical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
Sterile Back Surgical Gown with Hand Towel
The provided text is a 510(k) premarket notification letter from the FDA regarding a "Sterile Back Surgical Gown with Hand Towel." This document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to AI/ML device evaluation.
The letter is a regulatory approval document confirming that the device is substantially equivalent to legally marketed predicate devices and can proceed to market. It outlines general controls, potential additional controls, and contact information for further inquiries.
Therefore, I cannot fulfill your request for information regarding performance criteria and study details based on the provided text. The document does not describe a study involving "acceptance criteria," "reported device performance" in the context of quantitative metrics, "sample sizes," "ground truth," "expert consensus," "MRMC studies," or "standalone performance."
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.