(163 days)
The Lac-Mac, Limited, InnerBloc® LR Surgical Gowns, based on the GORE® LR Fabric, are reusable gowns that are intended to be worn by health care personnel during surgical and other medical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. For manufacturing, processing, or repackaging, these gowns must be reprocessed and packaged.
reusable gowns that are intended to be worn by health care personnel during surgical and other medical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
This document is an FDA 510(k) clearance letter for a surgical gown, not a study report for a medical device that uses AI or performs diagnostic tasks that would typically require acceptance criteria based on performance metrics like sensitivity, specificity, etc.
Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria, as it relates to performance metrics for a diagnostic or AI-driven device.
The document is a regulatory approval for a physical product (surgical gowns) based on substantial equivalence to a predicate device, which focuses on manufacturing, materials, and intended use as defined by existing regulations. It does not involve performance studies with test sets, ground truth, expert adjudication, or MRMC studies.
§ 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.