(170 days)
The Surgical Gown is intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate material. In addition, this surgical gown meets the requirements of AAMI Level 4 barrier protection for a surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). The Surgical Gowns are single use, disposable medical devices, provided sterile.
The Surgical Gown is composed of collar, body, sleeve and tie. The back is full opening, the neck and waist are laced, the sleeve are made of polyester elastic closure by sewing, and the rest are made of SMS nonwoven material, in a blue color. It has been tested according to AAMI PB70:2012 and meet AAMI Level 4 barrier level protection for a surgical gown. The proposed devices are single use, disposable medical devices and EO that sterilized. They are available in six sizes: S, M, L, XL, XXL and XXXL
This document describes the safety and performance of a Surgical Gown, not an AI-powered medical device. Therefore, many of the requested details about acceptance criteria for AI model performance and ground truth establishment are not applicable.
However, I can extract the relevant acceptance criteria and the reported device performance for the physical surgical gown based on the provided text.
Device: Surgical Gown (K222403)
Intended Use: To protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material during surgical procedures, meeting AAMI Level 4 barrier protection.
1. Table of Acceptance Criteria and Reported Device Performance
The device performance is assessed through non-clinical laboratory tests.
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|---|
| AATCC 42 | Assess resistance to water impact penetration | Level 4, ≤1.0g | Pass |
| AATCC 127 | Assess hydrostatic resistance | Level 4, ≥50cm | Pass |
| ASTM D5034 | Assess adequate tensile strength | Warp/Length ≥ 30N; Weft/Width ≥ 30N | Pass |
| ASTM D5587 | Assess adequate tear resistance | Warp/Length ≥ 10N; Weft/Width ≥ 10N | Pass |
| ASTM D1683 | Assess adequate seam strength | Sleeve Seam: ≥ 30N; Armhole Seam: ≥ 30N; Shoulder Seam: ≥ 30N | Pass |
| ASTM F1868 | Assess evaporative resistance of fabrics | (Ref)≥0.06(kPa·m²/W) | Pass |
| ASTM F1671 | Resistance to Penetration by Blood-Borne Pathogens using Phi-X174 Bacteriophage | No penetration (Assay Titer |
§ 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.