(56 days)
Surgical gown 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 Level 2 standard surgical gowns met the requirements for Level 2 classification, the Level 3 standard surgical gowns and Level 3 reinforced surgical gowns met the requirements for Level 3 classification.
The proposed devices are 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. The proposed devices are single use, disposable medical devices and are provided in sterile.
There are three types of surgical gown: Level 2 standard surgical gown, Level 3 standard surgical gown and Level 3 reinforced surgical gown. And each type of surgical gown is available in seven product sizes, including XS, S, M, L, XL, XXL and XXXL. The barrier protection level for Level 2 standard surgical gown meets AAMI Level 2, while the barrier protection level for Level 3 standard surgical gown and Level 3 reinforced surgical gown meet AAMI Level 3.
Acceptance Criteria and Device Performance Study for Surgical Gowns (K211422)
This document describes the acceptance criteria and the studies performed to demonstrate that the Jiangsu Medplus Non-woven Manufacturer Co., Ltd. Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, and Level 3 Reinforced Surgical Gown meet these criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Name of Testing Methodology | Acceptance Criteria (Proposed Device) | Reported Device Performance |
|---|---|---|
| Flammability (16 CFR Part 1610) | Meets Class 1 requirements | Pass |
| Hydrostatic pressure (AATCC 127: 2017) | Level 2 Standard Surgical Gown: >20 cm | |
| Level 3 Standard Surgical Gown: >50 cm | ||
| Level 3 Reinforced Surgical Gown: >50 cm | Level 2 Standard Surgical Gown: 37.6 cm | |
| Level 3 Standard Surgical Gown: 52.6 cm | ||
| Level 3 Reinforced Surgical Gown: 83.1 cm | ||
| Water impact (AATCC 42: 2017) | ≤1.0 g | Level 2 Standard Surgical Gown: 0.4 g |
| Level 3 Standard Surgical Gown: 0.5 g | ||
| Level 3 Reinforced Surgical Gown: 0.2 g | ||
| Breaking strength (ASTM D5034: 2009(2017)) | >20N | Level 2 Standard Surgical Gown: 73N |
| Level 3 Standard Surgical Gown: 70.3N | ||
| Level 3 Reinforced Surgical Gown: 45.6N | ||
| Tearing strength (ASTM D5587: 2015(2019)) | >20N | Level 2 Standard Surgical Gown: 24.1N |
| Level 3 Standard Surgical Gown: 48.4N | ||
| Level 3 Reinforced Surgical Gown: 24.6N | ||
| Linting (ISO 9073-10: 2003) | Log10 (particle count) 30 ft³/min/ft² | Level 2 Standard Surgical Gown: 32.9 ft³/min/ft² |
| Level 3 Standard Surgical Gown: 33.8 ft³/min/ft² | ||
| Level 3 Reinforced Surgical Gown: 31.7 ft³/min/ft² | ||
| EO/ECH Residue (ISO 11135:2014 Annex B) | EO: |
§ 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.