(195 days)
Surgical apparel that are intended to be worn by operating room personnel during surgical procedures to protect both the patient and personnel from transfer of microorganisms, body fluids and particulate material.
Surgeon's Gown, Poly Reinforced, Large
The provided text is a 510(k) clearance letter from the FDA for a Surgeon's Gown. This letter indicates that the device has been determined to be substantially equivalent to previously marketed devices. However, it does not contain any information about specific acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in the prompt.
Therefore, I cannot provide the requested table and details because the source document does not contain this type of information. The FDA 510(k) clearance process, especially for devices like surgical gowns, often relies on demonstrating substantial equivalence to pre-amendment devices or previously cleared predicate devices without necessarily requiring novel performance studies with detailed statistical metrics, ground truth, or expert adjudication as would be seen for complex diagnostic or AI-driven devices.
The letter focuses on regulatory compliance and the substantial equivalence determination based on the device's intended use (surgical apparel to protect from transfer of microorganisms, body fluids, and particulate material). It doesn't elaborate on the specific tests or their results that would prove this protection in a quantifiable manner, beyond likely referring to industry standards that the gown meets.
§ 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.