(178 days)
The Surgical Gown is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
This product is a new type of SMS breathable non-woven fabric. It consists of collar, gown body and sleeves. The main components of proposed device are: (1)One-piece non-woven fabric Surgical Gown: (2)One-piece helps for better protection and good visuals; (3)Lacing: It is used to tie the belt and fix the shape of the Surgical Gown.
The provided text is a 510(k) premarket notification for a Surgical Gown (K211077). It describes the device, its intended use, and a comparison to a predicate device, along with non-clinical performance test results.
This document does not describe an AI medical device or a study proving its performance. Therefore, I cannot provide the information requested in the prompt, as the questions pertain to the acceptance criteria and study design for an AI/Machine Learning (ML) medical device, including details about ground truth, expert adjudication, MRMC studies, and training/test set sample sizes.
The document is about a physical product (a surgical gown) and its substantial equivalence to another physical product based on material properties, strength, fluid resistance, etc., not a software-based AI device.
§ 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.