(209 days)
High protection 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 high protection surgical gown met the requirements for Level 4 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 device and is provided in sterile. The proposed device is available in five product sizes, including S, M, L, XL, XXL. The barrier protection level for high protection surgical gowns meet AAMI Level 4.
The medical device in question is a High Protection Surgical Gown (product code FYA, regulation number 21 CFR 878.4040, Class II).
Here's an analysis of its acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Flammability (16 CFR Part 1610) | Evaluate flammability of the test sample. | Meets requirements | Class 1 |
| Hydrostatic Pressure (AATCC 127) | Determine hydrostatic pressure of the test sample. | ≥50 cm H2O | 204.6 cm H2O |
| Water Impact (AATCC 127) | Determine hydrostatic pressure of the test sample (likely a typo, AATCC 42 is typically for impact penetration). | ≤1.0 g | 0.02g |
| Breaking Strength (ASTM D 5034) | Evaluate breaking strength of the test sample. | ≥30 N | Longitude: 131.5N, Latitude: 75.2N |
| Tearing Strength (ASTM D5587) | Evaluate tearing strength of the test sample. | ≥10 N | Longitude: 79.0N, Latitude: 33.8N |
| Linting (ISO 9073-10) | Evaluate linting of the test sample. | Log10(particle count) |
§ 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.