(129 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 surgical gown met the requirements for Level 3 classification.
The proposed device 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. The proposed device is single use, disposable medical devices and are provided in sterile. The surgical gown is available in six product sizes, including S, M, L, XL, XXL and XXXL. The barrier protection level for surgical gown met AAMI Level 3.
This document describes the non-clinical testing performed for a Surgical Gown (K211809) to demonstrate its equivalence to a predicate device. The information provided heavily focuses on physical and biological performance criteria.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Flammability | Evaluate the flammability of the test sample in accordance with 16 CFR Part 1610. | Meets requirements (implicitly Class 1, as per standard) | Class 1 Pass |
| Hydrostatic Pressure | Determine the hydrostatic pressure of the test sample in accordance with AATCC 127: 2017. | >50 cm | Average 72.05 cm |
| Water Impact | Evaluate the water impact of the test sample in accordance with AATCC 42: 2017. | ≤1.0 g | Average 0.45g |
| Breaking Strength | Evaluate the breaking strength of the test sample in accordance with ASTM D 5034:2009(2017). | >20N | MD: Average 74.88N |
| CD: Average 50.73N | |||
| Tearing Strength | Evaluate the tearing strength of the test sample in accordance with ASTM D5587:2015(2019). | >20N | MD: Average 63.87N |
| CD: Average 34.91N | |||
| Linting | Evaluate the linting of the test sample in accordance with ISO 9073-10:2003. | Log10(particle count) 30 ft³/min/ft² | Average 35.3 ft³/min/ft² |
| EO/ECH Residue (Ethylene Oxide Sterilization Residuals) | Evaluate the level of sterilant residues in accordance with ISO 10993-7:2008. | 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.