(135 days)
The AERO CHROME* Select Breathable Performance Surgical Gowns are sterile, single use surgical apparel intended to be worn by healthcate professionals to help protect both the healthcare worker from the transfer of microorganisms, body fluids, and particulate matter The AERO CHROME* Select Breathable Performance Surgical Gowns meet the Level 4 AAMI PB70:2012 Liquid Barrier classifications.
The AERO CHROME* A-Line Breathable Performance Surgical Gowns are surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of micro-organisms, body fluids, and particulate matter The AERO CHROME* A-Line Breathable Performance Surgical Gowns meet the Level 4 AAMI PB70 2012 Liquid Ba111er classifications.
The AERO CHROME* Select Breathable Performance Surgical Gowns have a SMS/F/SMS design (Spunbond-Meltblown-Spunbond/Film/Spunbond-Meltblown-Spunbond) that provides a PB70:2012 Level 4 Liquid Barrier Performance Barrier in the critical zone. The back of the gown is comprised of the identical fabric as the front of the gown and meets AAMI Level 1 Liquid Barrier Performance Barrier. The AERO CHROME* Select Breathable Performance Surgical Gown is a single use gown, supplied sterile (via Ethylene Oxide) or as bulk non-sterile product. The gowns come in the following various sizes: Large, X-Large, XX-Large.
The AERO CHROME* A-Line Breathable Performance Surgical Gowns have a SMS/F/SMS design (Spunbond-Meltblown-Spunbond/Film/Spunbond-Meltblown-Spunbond) that provides a PB70:2012 Level 4 Liquid Barrier Performance Barrier in the critical zone. The back of the gown is lightweight, air-breathable, and provides AAMI Level 1 protection. The AERO CHROME* A-Line Breathable Performance Surgical Gown is a single use gown, supplied sterile (via Ethylene Oxide) or as bulk non-sterile product. The gowns come in an X-Long, X- Large size.
The provided document describes the acceptance criteria and performance data for surgical gowns, not a medical device that uses algorithms or AI. Therefore, most of the requested information (sample sizes for test and training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment for training) is not applicable.
Below is a table summarizing the acceptance criteria and reported performance based on the non-clinical testing for the AERO CHROME* Select Breathable Performance Surgical Gown and AERO CHROME* A-Line Breathable Performance Surgical Gown.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method (Standard/Reference) | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Liquid Barrier Performance | ||
| ANSI/AAMI PB70:2012 Level 4 (Critical Zone) | Resistance to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage | Pass |
| ANSI/AAMI PB70:2012 Level 1 | Meets standard requirements for Level 1 Liquid Barrier | Pass |
| Synthetic Blood Penetration ASTM F1670 (2017) | Meets standard requirements for ASTM F1670 (2017) | Pass |
| Material Strength and Durability | ||
| Grab Tensile, Peak Stretch, and Peak Energy - Nonwovens ASTM D5034 - 9 2017 | Meets standard requirements for ASTM D5034 -9 2017 | Pass |
| Abrasion Resistance of Nonwoven Fabrics NWSP 020.5.RO (15) 2015 | Meets requirements of standard NWSP 020.5.RO (15) 2015 | Pass |
| Standard Test Method for Breaking Strength and Elongation of Textile Fabrics per ASTM D5034 | Pass (Identical to predicate) | Pass |
| Peel Strength per STM-00197 | LSL: >125 grams | Pass |
| Hydrohead Testing | Pass (Identical to predicate) | Pass |
| Abrasion Testing per STM-00149 | Pass (Identical to predicate) | Pass |
| Material Breathability/Particles | ||
| Water Vapor Transmission Rate NWSP 070.4.RO (15) 2015 | Meets standard requirements for NWSP 070.4.RO (15) 2015 | Pass |
| Water Vapor Transmission Rate of Materials (MOCON) | Pass (Identical to predicate) | Pass |
| Linting ISO 9073-10 2003 | Meets requirement for ISO 9073-10 2003 | Pass |
| Linting per ISO 9073-10 | Pass (Identical to predicate) | Pass |
| Air Permeability (Back of Gown) per STM-00162, NWSP 070.1.RO | Pass (Similar to predicate) | Pass |
| Biocompatibility & Safety | ||
| ISO L929 MEM Elution Cytotoxicity ISO 10993-5:2009 |
§ 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.