(171 days)
The Disposable 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 3 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 Disposable Surgical Gowns are single use, disposable medical devices, provided sterile.
The Disposable 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 heat sealing. It has been tested according to AAMI PB70:2012 and meet AAMI Level 3 barrier level protection for a surgical gown
This document is a 510(k) Premarket Notification from the FDA regarding a Disposable Surgical Gown. It evaluates the device's substantial equivalence to a legally marketed predicate device. The information provided is about the physical and performance characteristics of a surgical gown, not a diagnostic AI device requiring complex clinical studies or expert ground truth.
Therefore, many of the requested categories for AI/diagnostic device evaluation (like sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth for training) are not applicable to this type of medical device submission.
The "acceptance criteria" for this device are defined by a series of standardized non-clinical tests that measure physical properties and barrier performance.
Here's the relevant information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| AATCC 42 | Impact Penetration | Level 3, ≤1.0g | 70 cm for critical zone |
| ASTM D5034 | Tensile strength | Machine direction mean: ≥18 lbf; Cross direction mean: ≥12 lbf. | Machine direction mean: 21.95 lbf; Cross direction mean: 14.41 lbf. |
| ASTM D5587 | Tear resistance | Fabric direction A mean: ≥4.0 lbf; Fabric direction B mean: ≥2.5 lbf; | Fabric direction A mean: 5.09 lbf; Fabric direction B mean: 3.10 lbf; |
| ASTM D1683 | Seam strength | Shoulder: ≥8.5 lbf; Arm opening: ≥5.5 lbf; Sleeve: ≥8.5 lbf; | Shoulder: 10.8 lbf; Arm opening: 6.4 lbf; Sleeve: 10.2 lbf; |
| ISO 9073-10 | Side A (outside) IPM | Index for Particulate Matter (IPM): ≤2.5 | Index for Particulate Matter (IPM): 2.25 |
| ISO 9073-10 | Side B (inside) IPM | Index for Particulate Matter (IPM): ≤3.0 | Index for Particulate Matter (IPM): 2.85 |
| ISO 9073-10 | Side A&B IPM | Index for Particulate Matter (IPM): ≤3.0 | Index for Particulate Matter (IPM): 2.64 |
| ASTM F2407 | Evaporative resistance | Critical zone: ≥850 g/m²/24hrs; Non-critical zone: ≥850 g/m²/24hrs | Critical zone: 953.8 g/m²/24hrs; Non-critical zone: 930.2 g/m²/24hrs |
| 16 CFR Part 1610 | Flame spread | Class 1, Non Flammable | Class 1, Non Flammable |
| USP42-NF37 | Bacterial Endotoxins |
§ 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.