(361 days)
The SEJONG Surgical Gown Soft is sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker of microorganisms, body fluids, and particulate matter. The SEJONG Surgical Gown Soft meets the Level 3 requirements of ANSI/AAMI PB70:2012. Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities. The SEIONG Surgical Gown Soft has been validated using ethylene oxide (EtO) sterilization process. The SEJONG Surgical Gown Soft is also sold as bulk single-use, non-sterile, to repackager/relabeler establishments for further packaging and sterilization using the validated EO sterilization method according to ISO 11135 prior to being provided to the end user.
The SEJONG Level 3 Surgical Gowns is a non-reinforced design and available in 4 sizes ranging from medium to XX-large. Below Table provides model number of the Sejong Surgical Gown Soft. The chest and sleeve critical zones, as well as the overall body, are constructed from a blue polyolefin/polypropylene SMMMS (Spunbound, meltblown, meltblown, spunbound). Sejong Surgical Gown Soft has been tested according to ANSI/AAMI PB70:2012 and meets and AAMI Level 3 barrier level protection for a surgical gown. Sejong Surgical Gown Soft is nonreinforced, single use, disposable medical device that will be provided in both a sterile packaging configuration and a variety of sizes.
This document describes the premarket notification (510(k)) for the SEJONG Surgical Gown Soft, manufactured by Sejong Healthcare Co., Ltd. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device, the Medline Level 3 Surgical Gown (Sirus Non-Reinforced) (K190950).
As this is a 510(k) submission for a surgical gown, the "device" in question is not an AI/software medical device, but rather a physical apparel. Therefore, many of the typical acceptance criteria and study components associated with AI/software performance (such as sample sizes for test/training sets, data provenance, expert ground truth adjudication, MRMC studies, and human-in-the-loop performance) are not applicable here. The "performance" of this device is assessed through non-clinical laboratory testing to ensure it meets established safety and performance standards for surgical apparel.
Here's the breakdown of the information as it relates to the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria and performance data are presented in a table under Section VII. "Non-Clinical Test Conclusion."
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| AATCC 42 | Assess resistance to water impact penetration | Level 3, ≤1.0g | Pass |
| AATCC 127 | Assess hydrostatic resistance | Level 3, ≥50cm | Pass |
| ASTM D5034 | Assess adequate tensile strength | Length ≥ 30N | |
| Width ≥ 30N | Pass | ||
| ASTM D5587 | |||
| ASTM D5733 | Assess adequate tear resistance | Length ≥ 10N | |
| Width ≥ 10N | Pass | ||
| ASTM D1683 | Assess adequate seam strength | Sleeve Seam: ≥ 30N | |
| Armhole Seam: ≥ 30N | |||
| Shoulder Seam: ≥ 30N | Pass | ||
| Bursting Strength | |||
| ASTM D3787 | |||
| ISO 13938-1 | Assess adequate bursting resistance | ≥ 5.80 psi | Pass |
| ISO 9073-10 | Assess acceptable lint and other particles generation in the dry state | Log10 |
§ 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.