(178 days)
The PolyWear® Personal Protection Level 3 Gown is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. The PolyWear® Personal Protection Level 3 Gown is a single use, disposable gown provided non-sterile. The back of the gown is open and non-protective. The gown is not intended for use in the operating room.
The PolyWear® Personal Protection Level 3 Gown meets the requirements of AAMI Level 3 barrier protection for a protective gown per ANSI/AAMI PB70: 2012 Liquid Barrier Performance and Classification of protective apparel and drapes intended for use in healthcare facilities (AAMI PB70).
The PolyWear® Personal Protection Level 3 Gown is a single use, disposable gown provided non-sterile. The back of the gown is open and non-protective.
The provided text is a 510(k) clearance letter from the FDA for a medical device called the "PolyWear® Personal Protective Level 3 Gown." This document outlines the regulatory approval for the gown and its intended use, but it does not contain information about acceptance criteria for an AI/ML device, nor does it describe a study proving the device meets such criteria.
The document primarily focuses on:
- Regulatory Classification: Identifying the device as a Class II surgical apparel.
- Substantial Equivalence: Stating that the device is substantially equivalent to legally marketed predicate devices.
- General Controls: Listing the general regulatory requirements the manufacturer must adhere to.
- Indications for Use: Describing the intended purpose of the gown to protect against microorganisms, body fluids, and particulate material, specifically mentioning it meets AAMI Level 3 barrier protection.
Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance in the context of AI/ML, as this document pertains to a physical medical garment and not a software-based AI/ML 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.