(245 days)
Halyard Tri-Layer AAMI 3 Isolation Gowns are intended to be worn by healthcare personnel in isolations to provide moderate barrier protection for healthcare personnel and patients from microorganism transfer, body fluids, and particulate matter. The gowns are non-sterile, single use, and meet AAMI PB70:2012 level 3 Liquid Barrier performance requirements. Not intended for use in the operating room.
The Halyard Tri-Layer AAMI 3 Isolation Gown ("Isolation Gown") is a single use gown, supplied non-sterile. The gowns come in the following sizes: Large, X-Large. These surgical gowns are apparel that are intended to be worn by healthcare professionals to protect from varying levels of fluid contact (low to moderate). These surgical gowns meet the AAMI PB70:2012 Liquid Barrier Performance Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities, Level 3 Requirements. These Isolation Gowns are manufactured from three-layer full length polypropylene SMS material, with neck tape, elastic cuffs, and waist belt closure systems.
The provided document details the non-clinical testing performed on the Halyard Tri-Layer AAMI 3 Isolation Gowns to demonstrate their substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Method | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Spray Impact - Front/Back/Sleeve Panel | AATCC 42 | ≤ 1.0g | Pass |
| Spray Impact - Sleeve/Armhole Seam/Shoulder Seam | AATCC 42 | ≤ 1.0g | Pass |
| Spray Impact - Front Tie | AATCC 42 | ≤ 1.0g | Pass |
| Static Decay MD | STM-00180 | USL 0.5s | Pass |
| Static Decay CD | STM-00180 | USL 0.5s | Pass |
| ISO L929 MEM Elution Cytotoxicity | ISO 10993-5:2009 | ≤ Grade 2 (mild reactivity) | Pass |
| ISO Irritation Test | ISO 10993-10:2010 | ≤ 0.4 Primary Irritation (PII) | Pass |
| ISO Kligman Maximization Test | ISO 10993-10:2010 | Grade |
§ 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.