(103 days)
The Medical Surgical Gowns 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.
Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the Medical Surgical Gowns met the requirements for Level 3 classification.
The proposed device is a poly-reinforced surgical gown, the critical zone is front chest and sleeves. The critical zone is reinforced with PP/PE composite laminated material and the reinforced layer is attached with the gown by ultrasonic welding. The proposed device is available in five different sizes, include S-160, M-165, L-70, XL-175, XXL-180, and XXXL-185. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the proposed devices can meet the requirements for Level 3 classification. The proposed devices are disposable medical devices and provided in sterile.
This document is a 510(k) Pre-market Notification for a medical device, specifically Medical Surgical Gowns. The information provided does not describe an AI medical device or a study involving human readers.
Therefore, most of the requested points are not applicable. I can only extract information related to the performance of the Medical Surgical Gowns based on the provided text.
Here's a summary of the information that is available:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are generally based on the ANSI/AAMI PB70:2012 Level 3 classification for liquid barrier performance, along with specific physical and biological properties.
| Acceptance Criteria / Test | Performance (Proposed Device K202844) |
|---|---|
| Liquid Barrier Performance (ANSI/AAMI PB70:2012) | Met Level 3 classification |
| Hydrostatic pressure (AATCC 127) | >50 cm |
| Water impact (AATCC 42) | ≤1.0 g |
| Physical Properties | |
| Break strength (ASTM D 5034-09) | >20N |
| Tear strength (ASTM D 5587-15) | >20N |
| Air permeability (ASTM D737-18) | >15 cm3/s/cm2 (29 ft3/min/ft2) |
| Lint (ISO 9073-10) | Log10 |
§ 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.