(222 days)
The Dream Medi Sterile Surgical Gowns are 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 matter.
In addition, this surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/AAMI PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). This is a single use, disposable device, provided sterile.
Dream Medi Surgical Gowns are made from SMS material. They are full length, constructed with raglan sleeves, hook and loop neck closures, and tie waist closures. They provide AAMI Level-3 protection.
The Level 3 Gowns have five different sizes: Small (S), Medium (M), Large (L), Extra Large (XL), Extra Extra Large (XXL).
SMS is a multi-ply material consisting of layers of spunbond and meltblown polypropylene.
The body is made from 44g Blue SMS and the sleeve is made from 54g Blue SMS. Sleeve opening is made from pure polyester. The collar closure is made from dacron. All gowns are sterilized with ethylene oxide.
This document, a 510(k) Clearance Letter, describes the regulatory approval of a surgical gown (Dream Medi Sterile Surgical Gown), not a medical device that relies on complex algorithms, image analysis, or AI. Therefore, most of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/algorithm-driven device (e.g., sample size for test/training sets, expert ground truth, MRMC studies, standalone performance) is not applicable to this document.
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the performance of the surgical gown against established standards for protective apparel, as detailed in Section 8.0 "Summary of Non-Clinical Testing."
Here's a breakdown of the relevant information from the provided document, addressing the prompt as best as possible given the nature of the device:
1. Table of Acceptance Criteria and Reported Device Performance
| Purpose | Test | Acceptance Criteria (from AAMI Level 3) | Reported Device Performance (Results) |
|---|---|---|---|
| Impact Penetration | AATCC 42 | Level 3, ≤1.0 g | Pass |
| Hydrostatic Resistance | AATCC 127 | Level 3, ≥50 cm | Pass |
| Tensile strength | ASTM D5034 | ≥30 N (≥ 7 lbf) | Pass |
| Tear resistance | ASTM D5587 | ≥10 N (≥ 2.3 lbf) | Pass |
| Seam strength | ASTM D1683 | ≥30 N (≥ 7 lbf) | Pass |
| Lint and Other particles generation in the dry state | ISO 9073-10 | Log 10 |
§ 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.