(89 days)
The Standard Surgical Gown (AAMI Level 2) and Reinforced Surgical Gown (AAMI Level 2) are sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids, and particulate material.
The Standard Surgical Gown (AAMI Level 2) and Reinforced Surgical Gown (AAMI Level 2) meets the level 2 requirements of ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities.
The Standard Surgical Gown (AAMI Level 2) and Reinforced Surgical Gown (AAMI Level 2) have been validated using an ethylene oxide sterilization process. The Standard Surgical Gown (AAMI Level 2) and Reinforced Surgical Gown (AAMI Level 2) are also sold as bulk single-use, non-sterile, to repackager/relabeler establishments for further packaging and sterilization using the validated EtO sterilization method according to ISO 11135-1 prior to being provided to the end user.
Not Found
This document is a 510(k) summary for a medical device, specifically a Standard Surgical Gown (AAMI Level 2) and Reinforced Surgical Gown (AAMI Level 2). It outlines the FDA's determination of substantial equivalence. However, it does not contain information related to software algorithm performance, clinical study acceptance criteria, or the details of a study proving a device meets such criteria.
The document primarily focuses on:
- Regulatory Clearance: The FDA's decision that the device is substantially equivalent to legally marketed predicate devices.
- Indications for Use: The intended purpose of the surgical gowns (protection from microorganisms, body fluids, particulate matter) and their compliance with ANSI/AAMI PB70:2012 for liquid barrier performance (Level 2).
- Sterilization Method: Validation of ethylene oxide (EtO) sterilization.
- Device Models: A list of different models based on size, sterility, and whether they include hand towels and wrap.
Therefore, I cannot provide the requested information about acceptance criteria and study details from the provided text, as this document is a regulatory approval letter, not a performance study report.
§ 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.